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| ID | Type | Description | Link |
|---|---|---|---|
| IDE Number G130084 | Other Identifier | CDRH |
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This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).
The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and 3 OUS sites. Randomized 2:1.
The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-month post procedure follow-up visit.
The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the protocol for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convergent Procedure | Experimental | Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment |
|
| Standalone Endocardial Catheter Ablation | Active Comparator | Procedure/Surgery: Endocardial Catheter Ablation Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax | Device | Convergent Epicardial Endocardial Ablation Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL. | This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained. | 12 Months |
| Primary Safety Analysis | The primary safety analysis will measure the number of Major Adverse Events (MAE) collected from the start of the coagulation procedure to 30 days post procedure. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure. | The secondary safety endpoint for the study was the number of participants with serious adverse events (SAEs) in the study through the 12-months post-procedure. | 12 month |
| Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David DeLurgio, MD | Emory St Joseph's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | United States | ||
| Heart Center Research LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38590997 | Derived | Gill J, Crossen KJ, Blauth C, Kerendi F, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp D, Osorio J, Tabereaux P, Boedefeld W, Civello K, Ahsan S, Yap J, Billakanty S, Duff S, Costantini O, Espinal E, Kiser A, Shults C, Pederson D, Garrison J, Gilligan DM, Link MG, Kowalski M, Stees C, Sperling JS, Jacobowitz I, Yang F, Greenberg YJ, De Lurgio DB. Atrial fibrillation symptom reduction and improved quality of life following the hybrid convergent procedure: a CONVERGE trial subanalysis. Ann Cardiothorac Surg. 2024 Mar 29;13(2):155-164. doi: 10.21037/acs-2023-afm-15. Epub 2023 Aug 29. | |
| 33185144 |
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10 subjects were consented but withdrew prior to assignment to a treatment arm. 5 subjects were excluded by Investigator decision, 3 subjects withdrew consent for unkown reasons and 2 subjects withdrew based on insurance coverage considerations
Recruiting for the CONVERGE Study began with first site IRB approval Nov 13, 2013. Recruiting locations included physician offices, clinics and site clinical study offices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Convergent Procedure | Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure |
| 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 | Oct 2, 2017 | Mar 18, 2021 |
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2:1 randomized (Convergent Procedure versus standalone endocardial catheter ablation) multi-center pivotal clinical study
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| Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering | Device | Endocardial Catheter Ablation Procedure |
|
AF Burden Reduction of at Least 90% at 12-Months (ITT Population): The first secondary effectiveness endpoint in the fixed-sequence testing was defined as at least 90% reduction in AF burden, absent of an increased dose or new class I/III AADs, at 12 months compared to baseline. |
| 12 Months |
| AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's. | Number of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's | 12 Months |
| Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs. | Number of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group. | 12 Months |
| Change in Atrial Fibrillation Severity Scale (AFSS) | Change was calculated as the value at 12 months minus the value at baseline. The University of Toronto's Atrial Fibrillation Severity Scale (AFSS) is a composite score of overall subject-perceived severity, global well-being, atrial fibrillation frequency, and atrial fibrillation duration. The score ranges from 3 to 30, with higher scores indicating greater atrial fibrillation burden. | 12 months |
| Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36) | Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a physical composite score based on following subscales: limitations in physical activities because of health problems; limitations in usual role activities because of physical health problems; bodily pain; vitality (energy and fatigue); and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status. | 12 Months |
| Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36) | Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a mental composite score based on the following subscales: general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical and mental component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status. | 12 months |
| Change in 6-Minute Walk Score | 6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups. | 12 months |
| Change in Left Atrial Diameter | Change in Left Atrial Diameter at 6 months from baseline. | 6 Months |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Rose Medical Center / Medical Center of Aurora | Denver | Colorado | 80220 | United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| St. Vincent's HealthCare | Jacksonville | Florida | 32204 | United States |
| Mt Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Palm Beach Gardens Medical Center | Palm Beach Gardens | Florida | 33410 | United States |
| Emory University - St. Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| St. Vincent Medical Group Inc. | Indianapolis | Indiana | 46260 | United States |
| Cardiovascular Research Foundation of Louisiana | Baton Rouge | Louisiana | 70808 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Cardiology Associates Research, LLC | Tupelo | Mississippi | 38801 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| East Carolina University - Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| Wake Medical Center / Cary Research Group | Raleigh | North Carolina | 27518 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| Riverside Hospital / OhioHealth | Columbus | Ohio | 43214 | United States |
| UPMC Pinnacle Hospitals | Harrisburg | Pennsylvania | 17101 | United States |
| Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| Austin Heart PLLC | Austin | Texas | 78756 | United States |
| STAR Clinical Trials LLC | San Antonio | Texas | 78229 | United States |
| Virginia Cardiovascular Specialists | Richmond | Virginia | 23229 | United States |
| St. Bartholomew's Hospital | London | E1 1BB | United Kingdom |
| Guy's and St. Thomas Hospital | London | SE1 7EH | United Kingdom |
| Derived |
| DeLurgio DB, Crossen KJ, Gill J, Blauth C, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp DR, Kerendi F, Taigen TL, Shults CC, Shah MH, Rajendra AB, Osorio J, Silver JS, Hook BG, Gilligan DM, Calkins H. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e009288. doi: 10.1161/CIRCEP.120.009288. Epub 2020 Nov 13. |
| FG001 | Standalone Endocardial Catheter Ablation | Procedure/Surgery: Endocardial Catheter Ablation Treatment Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure |
|
| Treated |
|
| COMPLETED | enrollment complete 153 treated |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Convergent Procedure | Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure |
| BG001 | Standalone Endocardial Catheter Ablation | Procedure/Surgery: Endocardial Catheter Ablation Treatment Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Measure done in Centimeters. | Mean | Standard Deviation | cm |
| ||||||||||||||||
| Weight | Measure reported in Kilograms | Mean | Standard Deviation | Kilograms |
| ||||||||||||||||
| BMI | Measurements reported in Kg/M2 | Mean | Standard Deviation | Kg/M2 |
| ||||||||||||||||
| Smoking History | Count of Participants | Participants |
| ||||||||||||||||||
| Persistent AF | 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 | Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL. | This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Primary Safety Analysis | The primary safety analysis will measure the number of Major Adverse Events (MAE) collected from the start of the coagulation procedure to 30 days post procedure. | Posted | Number | Number of events | 30 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure. | The secondary safety endpoint for the study was the number of participants with serious adverse events (SAEs) in the study through the 12-months post-procedure. | Summary of Serious Adverse Events within 12 months occurring in >3% of the subjects in any treatment group (Safety Population) | Posted | Count of Participants | Participants | 12 month |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline | AF Burden Reduction of at Least 90% at 12-Months (ITT Population): The first secondary effectiveness endpoint in the fixed-sequence testing was defined as at least 90% reduction in AF burden, absent of an increased dose or new class I/III AADs, at 12 months compared to baseline. | The number of subjects in the EPi- Sense group that achieved at least 90% reduction at 12 months, compared to subjects in the Catheter Ablation group. | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's. | Number of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's | Posted | Mean | 95% Confidence Interval | percentage of participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs. | Number of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group. | Posted | Mean | 95% Confidence Interval | percentage of participants | 12 Months |
|
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| Secondary | Change in Atrial Fibrillation Severity Scale (AFSS) | Change was calculated as the value at 12 months minus the value at baseline. The University of Toronto's Atrial Fibrillation Severity Scale (AFSS) is a composite score of overall subject-perceived severity, global well-being, atrial fibrillation frequency, and atrial fibrillation duration. The score ranges from 3 to 30, with higher scores indicating greater atrial fibrillation burden. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36) | Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a physical composite score based on following subscales: limitations in physical activities because of health problems; limitations in usual role activities because of physical health problems; bodily pain; vitality (energy and fatigue); and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status. | Subjects evaluated for quality of life using SF- 36 survey. | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36) | Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a mental composite score based on the following subscales: general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical and mental component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 6-Minute Walk Score | 6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups. | Posted | Mean | Standard Deviation | Meters | 12 months |
|
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| Secondary | Change in Left Atrial Diameter | Change in Left Atrial Diameter at 6 months from baseline. | Posted | Mean | Standard Deviation | cm | 6 Months |
|
|
12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not.
SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study.
MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
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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 | Convergent Procedure | Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure | 2 | 102 | 97 | 102 | 9 | 102 |
| EG001 | Standalone Endocardial Catheter Ablation | Procedure/Surgery: Endocardial Catheter Ablation Treatment Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure | 0 | 51 | 41 | 51 | 0 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v 18.0 | Systematic Assessment |
| |
| Sinus Node Dysfunction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA v18.0 | Systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticular Perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Enterocutaneous Fistula | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal Haemorrage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Salivary Gland Mass | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Multi-Organ Disorder | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia Staphlyococcal | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Postoperative Wound Infectiion | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Nerve Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Post Procedure Haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Traumatic Haemothorax | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Vascular Access Complication | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Toponian Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vertebral Foraminal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Breast Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Kaposi's Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Mestastatic Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cervical Myelopathy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| viith Nerve Paralysis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute Respitory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic Respitory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Organising Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Plueral Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleuratic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac Ablation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| Colostomy Closure | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| knee Arthroplasty | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| Shoulder Arthroplasty | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertensive Emergency | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Jugular Vein Thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tamponade | Cardiac disorders | MedDRA (18.0) | Systematic Assessment | Major Adverse Event-Primary Safety Endpoint Measure (Safety Population) |
|
| Excessive Bleeding | Cardiac disorders | MedDRA (18.0) | Systematic Assessment | Major Adverse Event-Primary Safety Endpoint Measure (Safety Population) |
|
| Phrenic Nerve Injury | Nervous system disorders | MedDRA (18.0) | Systematic Assessment | Major Adverse Event-Primary Safety Endpoint Measure (Safety Population) |
|
| Stoke | General disorders | MedDRA (18.0) | Systematic Assessment | Major Adverse Event-Primary Safety Endpoint Measure (Safety Population) |
|
| Transient Ischemic Attack | Nervous system disorders | MedDRA (18.0) | Systematic Assessment | Major Adverse Event-Primary Safety Endpoint Measure (Safety Population) |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director of Clinical Education | AtriCure | 513-560-5974 | SGaynor@atricure.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2019 | Mar 18, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Past Smoker |
|
| Current Smoker |
|
| Unknown |
|
| Long-Standing Persistent AF |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
|
| Counts |
|---|
| Participants |
|
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