Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for P… (NCT06096337) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
United States484 participantsStarted 2023-12-28
Plain-language summary
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years of age, or older if specified by local law
✓. Have symptomatic persistent AF, confirmed by both:
✓. Willing and capable of providing informed consent
✓. Willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
✓. Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months(i.e., within 180 days of consent
Exclusion criteria
✕. Treated with AAD (Class I or III) ≤ 6 months (i.e., within 180 days) before enrollment,
✕. More than 7-day history of therapeutic AAD use (Class I or III), or
✕. ≥ 24 hours amiodarone, i Note Pill-in-the-pocket AAD use, is permitted.
✕. Treated with AAD ( Class I or III) \> 6 months (i.e., more than 180 days) before enrollment and experienced AAD failure (adverse drug effects or frequent AF episodes)
✕. Contraindication to, or unwillingness to use, AADs (Class I and III, excluding amiodarone)
✕. Contraindication to PFA treatment
✕. Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra-, and post-procedure to achieve adequate anticoagulation.
What they're measuring
1
Rate of randomized PFA or PFA Assigned subjects with PFA System inserted into the body, during the index or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious.
Timeframe: 12-Months
2
Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment.