Persistent Atrial Fibrillation
Conditions
Brief summary
PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation
Detailed description
This is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 75 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.
Interventions
DEVICEAblation
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 persistent AF meeting all three of the following criteria: 1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent. 2. ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days 3. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF 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
Subjects will be excluded from participating in this study if they meet any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety at 30 Days | 30 Days | Occurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula |
Countries
Croatia, Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FARAPULSE Endocardial Ablation Ablation using the FARAPULSE Endocardial Multi Ablation System
Ablation: Ablation using the FARAPULSE Endocardial Multi Ablation System | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | FARAPULSE Endocardial Ablation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 12 Participants | — |
| Age, Categorical Between 18 and 65 years | 16 Participants | — |
| Age, Continuous | 63.2 years STANDARD_DEVIATION 7.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Croatia | 12 Participants | — |
| Region of Enrollment Czechia | 16 Participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 13 / 28 |
| serious Total, serious adverse events | 4 / 28 |
Outcome results
Primary
Safety at 30 Days
Occurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Endocardial Ablation | Safety at 30 Days | 1 Participants |