ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study (ADVENT LTO)

Boston Scientific

Status: Invitation-only

Conditions: Paroxysmal Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT06526546

PF116

Details and patient eligibility

About

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.

Full description

This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.

Enrollment: 583 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria for this study.