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The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate persistent atrial fibrillation (PsAF) to either Normal Sinus Rhythm or Atrial Tachycardia compared to pulmonary vein isolation (PVI) in treating PsAF. The RHYTHMFINDER-192 catheter is investigational, while the CARTOFINDER™ system is CE marked in Europe.
All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation procedure for management of their persistent AF will be the target population for screening. The study will enroll approximately 40-70 subjects. Subjects will undergo CARTOFINDER™ guided ablation (CFGA) followed by PVI. Subjects will have follow-up visits at 7 days, 3, 6 and 12 months postprocedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | cartofinder guided ablation followed by PVI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cartofinder guided ablation followed by PVI | Procedure | cartofinder guided ablation followed by PVI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion). | Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CARTOFINDER Guided Ablation (CFGA) only (before Pulmonary Vein Isolation [PVI] and without cardioversion). | Up to 7 days |
| Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) and Pulmonary Vein Isolation (PVI) Without Cardioversion | Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CFGA and PVI without Cardioversion. | Up to 7 days |
| Percentage of Participants With Procedural Success | Procedural success defined as the conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia after overall ablation procedure, with or without the need for cardioversion. | Up to 7 days |
| Percentage of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, and Atrial Tachycardia Episodes of Greater Than or Equal to (>=) 30 Seconds to Measure the Effectiveness Success Rate for up to 12 Months | Documented AF/AT/AFL recurrence is defined as any occurrence of documented (symptomatic) atrial fibrillation, atrial flutter, and atrial tachycardia episodes >= 30 seconds during the post-blanking period (Day 91-365). Here 'HM' signifies Holter monitoring. | Up to 12 months |
| Number of Participants With Early-onset Primary Adverse Events | Incidence of early-onset (within 7 days of the initial mapping and ablation procedure) Primary Adverse Events (PAEs) was reported. PAEs included death, Atria-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Pericarditis and Major Vascular Access Complication/Bleeding. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Entrance Block After Adenosine/Isoproterenol Challenge | Number of participants with confirmed entrance block after adenosine/isoproterenol challenge was reported. | Up to 12 months |
| Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI |
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Inclusion Criteria:
Age > 18 years.
Patients who have signed the Patient Informed Consent Form (ICF)
Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of
In AF at the time of the baseline CARTOFINDER™ Map (spontaneous)
Left Atrium (LA) must demonstrate sufficient electrical activity to allow for the identification of ablation targets.
Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Aalst | Aalst | 9300 | Belgium | |||
| AZ Sint-Jan Brugge |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Persistent Atrial Fibrillation (PsAF) | Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Persistent Atrial Fibrillation (PsAF) | Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion). | Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CARTOFINDER Guided Ablation (CFGA) only (before Pulmonary Vein Isolation [PVI] and without cardioversion). | The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed. | Posted | Number | Percentage of participants | Up to 7 days |
|
Up to 12 months
The safety participants population included all enrolled participants who had the RHYTHMFINDE 192 Catheter inserted, regardless if CARTOFINDE-guided ablation was performed.
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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 | Participants With Persistent Atrial Fibrillation (PsAF) | Participants with PsAF and an ablation target on the CARTOFINDER (CF) map underwent CARTOFINDER-Guided Ablation (CFGA) followed by Pulmonary Vein Isolation (PVI) Wide Area Circumferential Ablation (WACA) ablation and followed-up at 7 days, 3 months, 6 months, and 12 months post ablation procedure. Participants not displaying an ablation target on CARTOFINDER were treated per investigator's standard of care and followed up until 7 days post-procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Macours / Clinical Research Director | Johnson and Johnson Medical NV/SA | +32 2 746 35 27 | nmacours1@its.jnj.com |
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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 | Sep 16, 2016 | Apr 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2017 | Apr 7, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Up to 7 days |
Change of intra-cycle length from pre-CFGA to post-CFGA and post-PVI is reported to measure the slowing for the overall Atrial Fibrillation rate in both atrium's. |
| Pre-CFGA (Baseline) to Post-CFGA and Post-PVI (Up to 7 days) |
| Number of Participants With Serious Adverse Device Effects (SADEs) up to 12 Months | Any serious adverse event which was related to the device and/or the procedure was defined as a SADE. | Up to 12 months |
| Number of Participants With All Serious Adverse Events (SAEs) up to 12 Months | Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above. | Up to 12 months |
| Number of Participants With Adverse Device Effects (ADEs) up to 12 Months | Number of participants with adverse device effects was reported. Adverse Device Effect (ADE's) are adverse events related to the use of an investigational medical device. This definition includes adverse events resulting from insufficient or inadequate instructions for use deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. This definition includes any event resulting from use errors or from intentional misuse of the investigational medical device. | Up to 12 months |
| Number of Participants With Procedural Related Serious Adverse Event and Non-serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. | Up to 12 months |
| Bruges |
| 8000 |
| Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2060 | Belgium |
| Southlake Regional Health Centre | Newmarket | Ontario | ON L3Y 2P9 | Canada |
| Nemocnice České Budějovice | České Budějovice | 370 01 | Czechia |
| St Bartholomew's hospital | London | EC1A 7BE | United Kingdom |
| London Health Sciences Center | London | W12 0NN | United Kingdom |
| Withdrew consent: 3-month FU visit |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) and Pulmonary Vein Isolation (PVI) Without Cardioversion | Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CFGA and PVI without Cardioversion. | The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed. | Posted | Number | Percentage of participants | Up to 7 days |
|
|
|
| Primary | Percentage of Participants With Procedural Success | Procedural success defined as the conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia after overall ablation procedure, with or without the need for cardioversion. | The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed. | Posted | Number | Percentage of participants | Up to 7 days |
|
|
|
| Primary | Percentage of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, and Atrial Tachycardia Episodes of Greater Than or Equal to (>=) 30 Seconds to Measure the Effectiveness Success Rate for up to 12 Months | Documented AF/AT/AFL recurrence is defined as any occurrence of documented (symptomatic) atrial fibrillation, atrial flutter, and atrial tachycardia episodes >= 30 seconds during the post-blanking period (Day 91-365). Here 'HM' signifies Holter monitoring. | Evaluable population:enrolled participants who had RHYTHMFINDER 192 Catheter inserted, where CFGA performed. 'N' (Number of participants analyzed):number of participants who completed 12 months follow-up(post initial ablation) or data collected from ElectroCardioGram, HM, or Post Procedure Arrhythmia Log forms beyond 337 days post index procedure. | Posted | Number | Percentage of participants | Up to 12 months |
|
|
|
| Primary | Number of Participants With Early-onset Primary Adverse Events | Incidence of early-onset (within 7 days of the initial mapping and ablation procedure) Primary Adverse Events (PAEs) was reported. PAEs included death, Atria-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Pericarditis and Major Vascular Access Complication/Bleeding. | The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed. | Posted | Count of Participants | Participants | Up to 7 days |
|
|
|
| Secondary | Number of Participants With Confirmed Entrance Block After Adenosine/Isoproterenol Challenge | Number of participants with confirmed entrance block after adenosine/isoproterenol challenge was reported. | Evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed. Here 'N' number of participants analyzed included participants with adenosine/isoproterenol challenge and non-missing confirmation of entry block data collected from the PVI form. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| Secondary | Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI | Change of intra-cycle length from pre-CFGA to post-CFGA and post-PVI is reported to measure the slowing for the overall Atrial Fibrillation rate in both atrium's. | Evaluable participant included all enrolled participants who had RHYTHMFINDER 192 Catheter inserted, where CARTOFINDER-guided ablation was performed. Here 'n' (number analyzed) included participants analyzed at specified categories for post-CFGA and post PVI. | Posted | Mean | Standard Deviation | milliseconds | Pre-CFGA (Baseline) to Post-CFGA and Post-PVI (Up to 7 days) |
|
|
|
| Secondary | Number of Participants With Serious Adverse Device Effects (SADEs) up to 12 Months | Any serious adverse event which was related to the device and/or the procedure was defined as a SADE. | The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| Secondary | Number of Participants With All Serious Adverse Events (SAEs) up to 12 Months | Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above. | The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| Secondary | Number of Participants With Adverse Device Effects (ADEs) up to 12 Months | Number of participants with adverse device effects was reported. Adverse Device Effect (ADE's) are adverse events related to the use of an investigational medical device. This definition includes adverse events resulting from insufficient or inadequate instructions for use deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. This definition includes any event resulting from use errors or from intentional misuse of the investigational medical device. | The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| Secondary | Number of Participants With Procedural Related Serious Adverse Event and Non-serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. | The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| 0 |
| 52 |
| 10 |
| 52 |
| 6 |
| 52 |
| Pericardial effusion | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Atrio-Esophageal Fistula |
|
| Death |
|
| Diaphragmatic Paralysis |
|
| Heart Block |
|
| Myocardial Infarction |
|
| Pneumothorax |
|
| Pulmonary Edema (Respiratory Insufficiency) |
|
| Pulmonary Vein Stenosis |
|
| Stroke / Cerebrovascular Accident |
|
| Thromboembolism |
|
| Transient Ischemic Attack |
|
|
| Right Atrium: Change post-CFGA |
|
|
| Right Atrium: Change post-PVI |
|
|