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The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Electrode RF Balloon Catheter | Device | Multi-Electrode RF Balloon Catheter will be inserted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter | An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. PAEs included myocardial infarction, thromboembolism, transient ischemic attack, phrenic nerve paralysis, major vascular access complication/bleeding, pericarditis, pulmonary edema (respiratory insufficiency), stroke/cerebrovascular accident (CVA), hospitalization (initial or prolonged), device or procedure related death, atrio-esophageal fistula, pulmonary vein stenosis. | Within 7 days post-procedure (Day of procedure = Day 0) |
| Number of Participants With Effectiveness Success | Effectiveness success was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to [>=] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram [ECG]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (example, entrainment or activation mapping) in an EP study. | From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Acute Procedural Success | Acute procedural success is defined as confirmation of entrance block in clinically relevant pulmonary veins (PVs) (all PVs except those that were silent and/or could not be cannulated) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter). | Day 0 (day of procedure) |
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Key Inclusion Criteria:
Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation.
Failed at least one Class I or Class III antiarrhythmic drug.
Age 18 -75 years.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Srinivas Dukkipati, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Moussa Mansour, MD | Massachusetts General Hospital | Principal Investigator |
| J. Brian Deville, MD | Baylor Research Institute | Principal Investigator |
| Sandeep Goysl, MD | Piedmont Hospital | Principal Investigator |
| Arash Aryana, MD | Mercy General Hospital | Principal Investigator |
| Javier Roman-Gonzalez, MD | Methodist Texsan Hospital | Principal Investigator |
| Hugh Calkins, MD | Johns Hopkins University | Principal Investigator |
| Suneet Mittal, MD | The Valley Hospital | Principal Investigator |
| Bradley Knight, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85018 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39686569 | Derived | Goyal SK, Pappone C, Grimaldi M, Lee SW, Mountantonakis S, DeVille JB, Sagi VS, Jiang CY, Jafri H, Wimmer AP, Wu LQ, Dukkipati S, Rashid H, Calkins H, Mansour M, Roman-Gonzalez J, Natale A, Ciconte G, Aryana A; STELLAR investigators. Multielectrode Radiofrequency Balloon Catheter for Paroxysmal Atrial Fibrillation: Results From the Global, Multicenter, STELLAR Study. J Cardiovasc Electrophysiol. 2025 Feb;36(2):376-386. doi: 10.1111/jce.16524. Epub 2024 Dec 16. |
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Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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As per protocol, enrolled participants who had signed informed consent form but did not meet eligibility criteria prior to insertion of the study catheter were considered as screen failures and excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Roll-in Phase | Participants enrolled in the roll-in phase with drug refractory, symptomatic paroxysmal atrial fibrillation (PAF) and were treated with the HELIOSTAR catheter in conjunction with the LassoStar catheter and Mutli-Channel radiofrequency (RF) Generator. |
| FG001 | Main Study |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2022 | Jul 18, 2025 |
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| Percentage of Participants With Alternative 12-Month Success | Alternative 12-month success is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, freedom from recurrence (captured on 12-lead ECG) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study. | From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0) |
| Percentage of Participants With 12-Month Symptomatic Recurrence | 12-month symptomatic recurrence endpoint is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) in participants regardless of antiarrhythmic drug (AAD) use and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, and freedom from recurrence (captured on 12-lead ECG) failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study. | From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0) |
| Change From Baseline in Quality of Life as Assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Scale Score | AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participant's HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1 to 18 evaluated HRQoL and questions 19 to 20 related to participant's satisfaction with treatment. Overall scores ranged from 0 to 100, where 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in QoL. Total score was calculated using AFEQT formula: 100 minus ([sum of severity for all questions answered minus number of questions answered]*100 / total number questions answered*6). | Baseline, Month 12 |
| Percentage of Participants With 12-Month Single Procedure Success | 12-month single procedure success is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, freedom from recurrence (captured on 12-lead ECG) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study. | From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0) |
| Northwestern Memorial Hospital |
| Principal Investigator |
| Anshul Patel, MD | Emory St Joseph's Hospital | Principal Investigator |
| Sung Lee, MD | Medstar Health Research Institute | Principal Investigator |
| Douglas Packer, MD | Mayo Clinic | Principal Investigator |
| Michael Panutich, MD | Hoag Memorial Hospital Presbyterian | Principal Investigator |
| Robert Sangrigoli, MD | Doylestown Hospital | Principal Investigator |
| Sharon Shen, MD | Vanderbilt Medical Center | Principal Investigator |
| Dhanunjaya Lakkireddy, MD | Kansas City Arrhythmia Research | Principal Investigator |
| Haseeb Jafri, MD | Kettering Medical Center | Principal Investigator |
| Timothy Mahoney, MD | Morristown Medical Center | Principal Investigator |
| Stavros Mountantonakis, MD | Lenox Hill Hospital | Principal Investigator |
| Massimo Grimaldi, MD | Miulli General Hospital | Principal Investigator |
| James Freeman, MD | Yale New Haven Hospital | Principal Investigator |
| Andy Voigt, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Venkata Sagi, MD | Baptist Health Research Institute | Principal Investigator |
| Anil Bhandari, MD | University of Southern California | Principal Investigator |
| Haroon Rashid, MD | Inova Health Care Services | Principal Investigator |
| Naushad Shaik, MD | AdventHealth Orlando | Principal Investigator |
| Alan Wimmer, MD | St. Luke's Hospital, Kansas City, Missouri | Principal Investigator |
| Frank Cuoco, MD | Trident Medical Center | Principal Investigator |
| Madhu Reddy, MD | University of Kansas Medical Center | Principal Investigator |
| Ryan Aleong, MD | University of Colorado, Denver | Principal Investigator |
| Andre Gauri, MD | Spectrum Health System | Principal Investigator |
| Raul Weiss, MD | Ohio State University | Principal Investigator |
| Craig Cameron, MD | Oklahoma Heart | Principal Investigator |
| MArwan Bahu, MD | Phoenix Cardiovascular Research Group | Principal Investigator |
| Darryl Wells, MD | Swedish Medical Center | Principal Investigator |
| Ethan Ellis, MD | Med Center of the Rockies | Principal Investigator |
| Carlo Pappone, MD | Policlinico Di San Donato Milanese | Principal Investigator |
| Abdi Rasekh, MD | CHI Baylor St. Lukes Medical Center | Principal Investigator |
| Liqun Wu, MD | Ruijin Hospital | Principal Investigator |
| Chenyang Jiang, MD | Sir Run Run Shaw Hospital | Principal Investigator |
| Los Angeles |
| California |
| 90033 |
| United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92618 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| University Of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Med Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Baptist Health Research Institute | Jacksonville | Florida | 32207 | United States |
| AdventHealth Orlando | Orlando | Florida | 32804. | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Emory St Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Kansas City Arrhythmia Research | Overland Park | Kansas | 66215 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Spectrum Health System | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 92618 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Lenox Hill Hospital - Northwell Health | New York | New York | 10075 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Oklahoma Heart | Tulsa | Oklahoma | 74101 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Trident Medical Center | Charleston | South Carolina | 29406 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| CHI Baylor St. Lukes Medical Center | Houston | Texas | 77030 | United States |
| Baylor Scott & White The Heart Hospital - Plano | Plano | Texas | 75093 | United States |
| Methodist Texsan Hospital | San Antonio | Texas | 78201 | United States |
| Inova Health Care Services | Falls Church | Virginia | 22042 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Ruijin Hospital | Rui Jin Er Road | Shanghai Municipality | 200025 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310020 | China |
| Policlinico Di San Donato Milanese | Milanesi | MI | Italy |
| Ospedale "F. Miulli" | Bari | Italy |
Participants enrolled in the main phase with drug refractory, symptomatic PAF, met eligibility criteria and had insertion of the HELIOSTAR catheter (with or without delivery of RF) in conjunction with the LassoStar catheter and Multi-Channel RF Generator. |
|
| Evaluable Participants | Participants who were enrolled and had study catheter inserted |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the radiofrequency (RF) delivery with the study catheters. Main study arm: Modified intent-to-treat (mITT) analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter.
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| ID | Title | Description |
|---|---|---|
| BG000 | Roll-in Phase | Participants enrolled in the roll-in phase with drug refractory, symptomatic paroxysmal atrial fibrillation (PAF) and were treated with the HELIOSTAR catheter in conjunction with the LassoStar catheter and Mutli-Channel radiofrequency (RF) Generator. |
| BG001 | Main Study | Participants enrolled in the main phase with drug refractory, symptomatic PAF, met eligibility criteria and had insertion of the HELIOSTAR catheter (with or without delivery of RF) in conjunction with the LassoStar catheter and Multi-Channel RF Generator. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter | An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. PAEs included myocardial infarction, thromboembolism, transient ischemic attack, phrenic nerve paralysis, major vascular access complication/bleeding, pericarditis, pulmonary edema (respiratory insufficiency), stroke/cerebrovascular accident (CVA), hospitalization (initial or prolonged), device or procedure related death, atrio-esophageal fistula, pulmonary vein stenosis. | Roll-in arm: Roll-in analysis set- participants who were enrolled in the roll-in phase and had undergone the radiofrequency (RF) delivery with the study catheters. Main study arm: Modified intent-to-treat (mITT) analysis set- enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. N (overall number of participants analyzed): participants evaluable for this outcome measure. Participants with missing values were excluded from the analysis. | Posted | Count of Participants | Participants | Within 7 days post-procedure (Day of procedure = Day 0) |
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| Primary | Number of Participants With Effectiveness Success | Effectiveness success was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to [>=] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram [ECG]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (example, entrainment or activation mapping) in an EP study. | Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0) |
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| Secondary | Percentage of Participants With Acute Procedural Success | Acute procedural success is defined as confirmation of entrance block in clinically relevant pulmonary veins (PVs) (all PVs except those that were silent and/or could not be cannulated) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter). | Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Day 0 (day of procedure) |
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| Secondary | Percentage of Participants With Alternative 12-Month Success | Alternative 12-month success is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, freedom from recurrence (captured on 12-lead ECG) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study. | Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Number | percentage of participants | From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0) |
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| Secondary | Percentage of Participants With 12-Month Symptomatic Recurrence | 12-month symptomatic recurrence endpoint is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) in participants regardless of antiarrhythmic drug (AAD) use and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, and freedom from recurrence (captured on 12-lead ECG) failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study. | Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Number | percentage of participants | From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0) |
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| Secondary | Change From Baseline in Quality of Life as Assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Scale Score | AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participant's HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1 to 18 evaluated HRQoL and questions 19 to 20 related to participant's satisfaction with treatment. Overall scores ranged from 0 to 100, where 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in QoL. Total score was calculated using AFEQT formula: 100 minus ([sum of severity for all questions answered minus number of questions answered]*100 / total number questions answered*6). | Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed): participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 12 |
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| Secondary | Percentage of Participants With 12-Month Single Procedure Success | 12-month single procedure success is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) and freedom from the following failure modes: freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from DC Cardioversion failure, freedom from recurrence (captured on 12-lead ECG) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study. | Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Number | percentage of participants | From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0) |
|
From pre-procedure on Day 0 up to Month 12
All-cause mortality: All enrolled roll-in phase participants and all-enrolled main study participants. Serious/other AEs: For main study, safety analysis set (enrolled participants who had insertion of study catheter); For roll-in phase, roll-in analysis set (all participants who were enrolled in the roll-in phase and had undergone the radiofrequency (RF) delivery with the study catheters).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Roll-in Phase | Participants enrolled in the roll-in phase with drug refractory, symptomatic paroxysmal atrial fibrillation (PAF) and were treated with the HELIOSTAR catheter in conjunction with the LassoStar catheter and Mutli-Channel radiofrequency (RF) Generator. | 0 | 117 | 19 | 94 | 42 | 94 |
| EG001 | Main Study | Participants enrolled in the main phase with drug refractory, symptomatic PAF, met eligibility criteria and had insertion of the HELIOSTAR catheter (with or without delivery of RF) in conjunction with the LassoStar catheter and Multi-Channel RF Generator. | 2 | 280 | 50 | 260 | 97 | 260 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Polymenorrhagia | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Iliac vein perforation | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Internal haemorrhage | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cardiac amyloidosis | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastric hypomotility | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Puncture site haemorrhage | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis shigella | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Infected bite | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chemical burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oesophageal injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Heart sounds abnormal | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Computerised tomogram liver | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Helicobacter test positive | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cerebral arteriosclerosis | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Laryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pulmonary vein stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
All information concerning the study, investigational medical device, sponsor operations, patent application, manufacturing processes, and basic scientific data supplied by the sponsor to the investigator and not previously published, are considered confidential and remain the sole property of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research | Biosense Webster, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2022 | Jul 18, 2025 | SAP_005.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Unknown or Not Reported |
|
| OG001 | Main Study | Participants enrolled in the main phase with drug refractory, symptomatic PAF, met eligibility criteria and had insertion of the HELIOSTAR catheter (with or without delivery of RF) in conjunction with the LassoStar catheter and Multi-Channel RF Generator. |
|
|
|
|
| OG001 |
| Main Study |
Participants enrolled in the main phase with drug refractory, symptomatic PAF, met eligibility criteria and had insertion of the HELIOSTAR catheter (with or without delivery of RF) in conjunction with the LassoStar catheter and Multi-Channel RF Generator. |
|
|
| OG001 | Main Study | Participants enrolled in the main phase with drug refractory, symptomatic PAF, met eligibility criteria and had insertion of the HELIOSTAR catheter (with or without delivery of RF) in conjunction with the LassoStar catheter and Multi-Channel RF Generator. |
|
|
| OG001 | Main Study | Participants enrolled in the main phase with drug refractory, symptomatic PAF, met eligibility criteria and had insertion of the HELIOSTAR catheter (with or without delivery of RF) in conjunction with the LassoStar catheter and Multi-Channel RF Generator. |
|
|
| OG001 |
| Main Study |
Participants enrolled in the main phase with drug refractory, symptomatic PAF, met eligibility criteria and had insertion of the HELIOSTAR catheter (with or without delivery of RF) in conjunction with the LassoStar catheter and Multi-Channel RF Generator. |
|
|