Paroxysmal Atrial Fibrillation
Conditions
Keywords
Catheter Ablation, Paroxysmal Atrial Fibrillaltion, Pulmonary Vein Isolation, Atrial Fibrillation
Brief summary
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).
Detailed description
This is a prospective, multi-center, single arm safety and effectiveness pilot study. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.
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 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 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 |
|---|---|---|
| Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events | 7 days to12 Months | Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period. |
| Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | 12 months | Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure. |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intent To Treat (ITT) Enrolled subjects who undergo one or more ablation at the index procedure using the study device. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Intent To Treat (ITT) | — |
|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 13.2 | — |
| Body Mass Index | 27.3 kg/m2 STANDARD_DEVIATION 3.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Croatia | 15 Participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| Time Between First Documented Atrial Fibrillation Diagnosis and Enrollment | 12.2 months STANDARD_DEVIATION 11.1 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 11 / 15 |
| serious Total, serious adverse events | 5 / 15 |
Outcome results
Primary
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Endocardial Ablation | Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | 10 Participants |
Primary
Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events
Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.
Time frame: 7 days to12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Endocardial Ablation | Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events | 0 Participants |