Paroxysmal Atrial Fibrillation
Conditions
Keywords
Persistent Atrial Fibrillation, Pulsed Field Ablation, Cardiovascular Heart Diseases, Antiarrhythmic Anticoagulation, Cardiac monitor, Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
Brief summary
The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.
Detailed description
This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation. * Subjects who were enrolled, randomized and treated for paroxysmal atrial fibrillation, classified as Modified Intention-to-Treat subjects, and completed the 12-Month Follow-Up in the FARAPULSE ADVENT Trial (CIP CS0934; NCT04612244). * Subjects or legally authorized representatives who are willing and capable of providing informed consent. * Subjects who are willing to comply with the protocol requirements.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic success in ADVENT Trial treated subjects compared between treatment groups. | 90 day-3 years | Occurrence of any of the following between the end of the Blanking Period (Day 90) in the ADVENT Trial through completion of follow-up in the ADVENT LTO study: Detectable AF, AFL+, or AT * ≥ 30 seconds in duration as adjudicated within the ADVENT Trial * Investigator assessed ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care\* at the study center post-ADVENT Trial completion * ≥ 30 seconds in duration recorded on the Holter monitor collected during the ADVENT Trial and the 3-4 Year Holter Monitor. * ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG Any Cardioversion for AF, AFL, or AT Re-ablation for AF, AFL, or AT |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVivek Reddy
MOUNT SINAI HOSPITAL
Outcome results
None listed