Paroxysmal Atrial Fibrillation
Conditions
Brief summary
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
Detailed description
This is a prospective, multi-center, safety and feasibility study. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PEF ablation of additional arrhythmogenic locations. Subjects will be followed at 30 days, 75 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.
Interventions
DEVICEFARAPULSE Endocardial Multi Ablation System
Ablation using the FARAPULSE Endocardial Multi Ablation System
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 75 Years
Healthy volunteers
No
Inclusion criteria
Study subjects are required to meet all the following inclusion criteria to participate in this study: 1. Patients with documented drug-resistant symptomatic PAF meeting all three of the following criteria: 1. Confirmed AF: Documentation must include a recording such as ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, or telemetry strip, 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 atrial fibrillation drug (AFD) treatment, meaning therapeutic failure of at least one 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure. | 30 Days | Number of patients with death, MI, diaphragmatic paralysis, stroke/TIA, thromboemolism, pericarditis, tamponade/perforation, vascular access complications, hospitalization, heart block, PV stenosis, atrioesophageal fistula. |
| Feasibility: Acute Key Procedural Success | Index Procedure | The primary feasibility endpoint for this study is 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 Multi 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
Croatia, Czechia
Participant flow
Recruitment details
A total of 10 subjects consented and were treated.
Pre-assignment details
A total of 10 patients were enrolled (signed informed consent) and 10 subjects were treated at two (2) sites in Europe.
Participants by arm
| Arm | Count |
|---|---|
| FARAPULSE Endocardial Ablation Ablation using the FARAPULSE Endocardial Multi Ablation System
FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | FARAPULSE Endocardial Ablation | — |
|---|---|---|
| AF History (number of months) | 20.98 Months STANDARD_DEVIATION 0.1 | — |
| Age, Continuous | 56.0 years STANDARD_DEVIATION 14.2 | — |
| Any History of Structural heart disease | 0 Participants | — |
| Body Mass Index | 26.9 kg/m^2 STANDARD_DEVIATION 3.3 | — |
| Cardiac Surgery | 0 Participants | — |
| Cerebrovascular disease | 1 Participants | — |
| CHA2DS2VASC | 1.8 units on a scale STANDARD_DEVIATION 1.7 | — |
| COPD | 0 Participants | — |
| Diabetes | 1 Participants | — |
| Dyslipidemia | 3 Participants | — |
| Hypertension | 6 Participants | — |
| Hyperthyroidism | 0 Participants | — |
| Hypothyroidism | 3 Participants | — |
| Left Atrial Diameter | 3.9 cm STANDARD_DEVIATION 0.4 | — |
| LVEF % | 61.9 Percentage of Left ventricular ejection STANDARD_DEVIATION 5 | — |
| Myocardial infarction | 0 Participants | — |
| NYHA Heart Failure Class I | 0 Participants | — |
| NYHA Heart Failure Class II | 3 Participants | — |
| NYHA Heart Failure Class III | 0 Participants | — |
| NYHA Heart Failure Class IV | 0 Participants | — |
| Pace Maker/Implantable Cardioverter Defibrillator | 0 Participants | — |
| Patient that failed any AntiArrhythmic Drugs | 10 Participants | — |
| Peripheral vascular disease | 0 Participants | — |
| Pulmonary hypertension | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Croatia | 5 participants | — |
| Region of Enrollment Czechia | 5 participants | — |
| Renal dysfunction/failure | 1 Participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
| Sleep apnea | 0 Participants | — |
| Smoking | 1 Participants | — |
| Unstable angina | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Feasibility: Acute Key Procedural Success
The primary feasibility endpoint for this study is 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 Multi 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: Index Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FARAPULSE Endocardial Ablation | Feasibility: Acute Key Procedural Success | 1.0 Proportion of subjects |
Primary
Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure.
Number of patients with death, MI, diaphragmatic paralysis, stroke/TIA, thromboemolism, pericarditis, tamponade/perforation, vascular access complications, hospitalization, heart block, PV stenosis, atrioesophageal fistula.
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Endocardial Ablation | Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure. | 0 Participants |