Concomitant LAAC/AF Ablation (Watchman FLX Pro)

Launched by HEART RHYTHM CLINICAL AND RESEARCH SOLUTIONS, LLC · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a combined treatment approach for people with atrial fibrillation (AF), a common heart rhythm problem. It looks at patients who have a procedure to fix their heart rhythm (called AF ablation) along with a procedure to close off a small part of the heart (called the left atrial appendage closure or LAAC) using a device named Watchman FLX Pro. The goal is to understand how well and safely these two procedures work when done together.

People who might be eligible for this study are adults who doctors have decided can benefit from the LAAC procedure and are already scheduled to have the AF ablation. Participants need to agree to take part in this extra study. Those who are involved in other related studies cannot join this one. If you take part, you can expect to have both procedures done during the same visit, and the study team will observe your health outcomes to learn more about this treatment combination. This study is currently recruiting patients and includes both men and women between the ages of 65 and 74.

Gender

ALL

Eligibility criteria

• Inclusion Criteria: All inclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study must meet the additional inclusion criteria below:
• • Patients who are determined by physicians to be eligible for LAAC
• • Patients whose LAAC with Watchman FLX Pro procedures are performed concomitant following AF ablation procedure
• • Willing and able to provide additional informed consent to the sub-study (unless waiver of consent is obtained)
• Exclusion Criteria: All exclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study have the additional exclusion criteria below:
• • -Patients who are participating in other DISRUPT-AF sub-studies