Paroxysmal Atrial Fibrillation
Conditions
Keywords
Catheter Ablation, Pulmonary Vein Isolation (PVI), Atrial Fibrillation (AF), Atrial Flutter, Atrial Tachycardia, Pulsed Field Ablation, Cavo-tricuspid isthmus, Anti-arrhythmic drugs, Atrial Fibrillation Drugs, Cardiac Arrhythmias, Cardiac Ablation, Cardiovascular Diseases, Heart Diseases
Brief summary
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
Detailed description
The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF). The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure. The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 \ 36 months of follow-up post-pulsed field ablation procedure. The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34\ 36 months of follow-up post-pulsed field ablation procedure.
Interventions
A pulmonary vein isolation will be performed using catheter ablation
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of paroxysmal atrial fibrillation (PAF), AND * Two (2) or more episodes of recurrent PAF during the 6 months preceding the consent Date, AND * At least 1 episode of Atrial Fibrillation (AF) documented with a tracing within 12 months preceding the consent date. * Age 18 years or older * Therapeutic Failure for the treatment of Atrial Fibrillation (effectiveness or intolerance) of at least one active antiarrhythmic drug (AAD) for rhythm control. * Willing and Capable of providing Informed Consent to undergo study procedures AND * Participate in all examinations and follow-up visits and tests associated with this clinical study
Exclusion criteria
* Any previous left atrial (LA) ablation (except permissible retreatment subjects) * Any previous LA surgery * Current intracardiac thrombus (can be treated after thrombus is resolved) * Presence of any pulmonary vein stents * Presence of any pre-existing pulmonary vein stenosis * Body Mass Index (BMI) \>45.0 * Anteroposterior Left Atrial diameter \> 5.5 cm by transthoracic echocardiography (TTE)/ intracardiac imaging (ICE) * Presence of any cardiac valve prosthesis * Clinically significant mitral valve regurgitation or stenosis * Myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angiography (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date * Unstable angina * Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date * Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO) * New York Heart Association (NYHA) class III or IV congestive heart failure * Left ventricular ejection fraction (LVEF) \< 35% * 2º (Type II) or 3º atrioventricular block * Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function) * Hypertrophic cardiomyopathy * Active Systemic infection * Uncontrolled hyperthyroidism * Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date. * Any woman known to be pregnant * Solid organ or hematologic transplant, or currently being evaluated for an organ transplant * Severe lung disease, pulmonary hypertension, or any lung disease associated with chronic abnormal blood gases or requiring supplemental oxygen * Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant * Active malignancy, or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma) * Life expectancy less than one (1) year * Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study (data collection for registries or retrospective studies is permitted) * Unwilling or unable to comply fully with study procedures and follow-up * Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements * Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus, untreated sleep apnea or active alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | 12 Months | Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure |
| Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months | 12 Months | To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE | 12 Months | Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event. |
| Additional Performance Analyses: Acute Procedural Success | 1 day | Acute Procedural success is the demonstration of Acute Vein Success (measured by % subjects) was determined by Isolation of an ablated PVI using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure), as clinically assessed by entrance block demonstrated ≥ 20 minutes after the last PVI lesion is made with or without adenosine testing |
Countries
Belgium, Czechia, Denmark, Germany, Netherlands, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FARAPULSE Pulsed Field Ablation System Ablation using the FARAPULSE Pulsed Field Ablation System
FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation | 180 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | FARAPULSE Pulsed Field Ablation System | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 80 Participants | — |
| Age, Categorical Between 18 and 65 years | 100 Participants | — |
| Age, Continuous | 62.3 years STANDARD_DEVIATION 10.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 28 participants | — |
| Region of Enrollment Czechia | 63 participants | — |
| Region of Enrollment Denmark | 12 participants | — |
| Region of Enrollment Germany | 50 participants | — |
| Region of Enrollment Netherlands | 18 participants | — |
| Region of Enrollment Switzerland | 9 participants | — |
| Sex: Female, Male Female | 70 Participants | — |
| Sex: Female, Male Male | 110 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 180 |
| other Total, other adverse events | 9 / 180 |
| serious Total, serious adverse events | 25 / 180 |
Outcome results
Primary
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure
Time frame: 12 Months
Population: Modified Intent To Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | 121 Participants |
Primary
Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months
To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD)
Time frame: 12 Months
Population: Modified Intent To Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months | 2 Participants |
Secondary
Additional Performance Analyses: Acute Procedural Success
Acute Procedural success is the demonstration of Acute Vein Success (measured by % subjects) was determined by Isolation of an ablated PVI using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure), as clinically assessed by entrance block demonstrated ≥ 20 minutes after the last PVI lesion is made with or without adenosine testing
Time frame: 1 day
Population: Modified Intent To Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Additional Performance Analyses: Acute Procedural Success | 180 Participants |
Secondary
Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE
Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event.
Time frame: 12 Months
Population: Modified Intent To treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE | Participants free from any of the procedure related SAE | 173 Participants |
| FARAPULSE Pulsed Field Ablation System | Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE | Participants free from any of the device related SAE | 179 Participants |