Paroxysmal Atrial Fibrillation
Conditions
Brief summary
PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial fibrillation.
Detailed description
Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the FARAPULSE Endocardial Ablation System. Subjects will be followed at 7 days, 30 days, 75 days, 6 months, and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the PEF (pulsed electric field) catheter ablation procedure.
Interventions
DEVICEFARAPULSE Endocardial Ablation System
Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the FARAPULSE Endocardial Ablation System.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with documented drug resistant symptomatic PAF who have: 1. Confirmed AF: Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, telemetry strip or similar, recorded within one year prior to enrollment and showing at least 30 seconds of AF. 2. Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment. 3. Failed AFD, meaning therapeutic failure of at least one antiarrhythmic drug (AFD; class I - IV) for efficacy and / or intolerance 2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment. 3. Patient participation requirements: 1. Lives locally 2. Is willing and capable of providing Informed Consent to undergo study procedures 3. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.
Exclusion criteria
1. Use of amiodarone within 3 months prior to enrollment 2. Atrial fibrillation that is any of the following 1. Persistent (by diagnosis or duration \> 7 days) 2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes 3. Requires ≥ 3 cardioversions in the preceding 12 months 3. Cardiac anatomical exclusions by imaging within 3 months prior to enrollment: 1. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) 2. Left ventricular ejection fraction ≤ 40% as documented by TTE 4. Any of the following cardiac procedures, implants or conditions: 1. Clinically significant arrhythmias other than AF 2. Hemodynamically significant valvular disease 3. Prosthetic heart valve 4. NYHA Class III or IV CHF 5. Previous endocardial or epicardial ablation or surgery for AF 6. Atrial or ventricular septal defect closure 7. Atrial myxoma 8. Left atrial appendage device or occlusion 9. Pacemaker, ICD or CRT 10. Significant or symptomatic hypotension 11. Bradycardia or chronotropic incompetence 12. History of pericarditis 13. History of rheumatic fever 5. Any of the following within 3 months of enrollment: 1. Myocardial infarction 2. Unstable angina 3. Percutaneous coronary intervention 4. Heart surgery including coronary artery bypass grafting 5. Heart failure hospitalization 6. Stroke or TIA 7. Clinically significant bleeding 8. Pericarditis or pericardial effusion 9. Left atrial thrombus 6. History of blood clotting or bleeding abnormalities. 7. Contraindication to, or unwillingness to use, systemic anticoagulation 8. Contraindications to CT or MRI 9. Sensitivity to contrast media not controlled by premedication 10. Women of childbearing potential who are pregnant, lactating or not using birth control 11. Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation, including but not limited to 1. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant 2. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea 3. Chronic renal insufficiency of \< 60 mL/min/1.73 m2, any history of renal dialysis, or history of renal transplant 4. Active malignancy or history of treated cancer within 24 months of enrollment 5. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux 6. Clinically significant infection 7. Predicted life expectancy less than one year 12. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements 13. Current or anticipated enrollment in any other clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint for This Study is the Composite Safety Endpoint (CSE) Defined as the Proportion of Patients With Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related. | 30 days~12 Months | Early onset (within 30 days of any endocardial ablation for atrial fibrillation). Occurrence of any one of the below events will qualify a subject as a safety failure. * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications * Hospitalization (initial or prolonged)\* * Heart block * Late onset (any time during follow-up) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula \* Excludes hospitalization (initial & prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Pulmonary Vein Isolation | 1 Day (Acute) | The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Ablation System during the first procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made. |
Countries
Czechia, France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FARAPULSE Endocardial Ablation Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.
FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System. | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | FARAPULSE Endocardial Ablation | — |
|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 10.5 | — |
| Any History of Structural heart disease | 3 Participants | — |
| Atrial Fibrillation history (number of months) | 16.61 months STANDARD_DEVIATION 23.94 | — |
| BMI | 28.3 kg/m^2 STANDARD_DEVIATION 4.4 | — |
| Cardiac Surgery | 2 Participants | — |
| Cerebrovascular disease | 6 Participants | — |
| CHA2DS2VASC | 1.8 units on a scale STANDARD_DEVIATION 1.6 | — |
| COPD | 1 Participants | — |
| Diabetes | 7 Participants | — |
| Dyslipidemia | 24 Participants | — |
| Hypertension | 42 Participants | — |
| Hyperthyroidism | 3 Participants | — |
| Hypothyroidism | 9 Participants | — |
| Left atrial diameter | 4.1 cm STANDARD_DEVIATION 0.5 | — |
| LVEF % | 62.1 percentage of left ventricular ejection STANDARD_DEVIATION 6.3 | — |
| Myocardial infarction | 3 Participants | — |
| NYHA Heart Failure Class I | 18 Participants | — |
| NYHA Heart Failure Class II | 3 Participants | — |
| NYHA Heart Failure Class III | 0 Participants | — |
| NYHA Heart Failure Class IV | 0 Participants | — |
| Patient that failed any AntiArrhythmic Drugs | 69 Participants | — |
| Peripheral vascular disease | 3 Participants | — |
| PPM/ICD | 0 Participants | — |
| Pulmonary hypertension | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Czechia | 50 participants | — |
| Region of Enrollment France | 21 participants | — |
| Renal dysfunction/failure | 1 Participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 56 Participants | — |
| Sleep apnea | 3 Participants | — |
| Smoking | 38 Participants | — |
| Unstable angina | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 17 / 71 |
| serious Total, serious adverse events | 11 / 71 |
Outcome results
Primary
The Primary Safety Endpoint for This Study is the Composite Safety Endpoint (CSE) Defined as the Proportion of Patients With Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related.
Early onset (within 30 days of any endocardial ablation for atrial fibrillation). Occurrence of any one of the below events will qualify a subject as a safety failure. * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications * Hospitalization (initial or prolonged)\* * Heart block * Late onset (any time during follow-up) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula \* Excludes hospitalization (initial & prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical).
Time frame: 30 days~12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Endocardial Ablation | The Primary Safety Endpoint for This Study is the Composite Safety Endpoint (CSE) Defined as the Proportion of Patients With Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related. | 2 Participants |
Secondary
Feasibility: Pulmonary Vein Isolation
The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Ablation System during the first procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.
Time frame: 1 Day (Acute)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FARAPULSE Endocardial Ablation | Feasibility: Pulmonary Vein Isolation | 1.0 Proportion of participants |