Concomitant LAAC/AF Ablation (Watchman FLX Pro)
ConditionPFA Ablation and LAAC Procedures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart Rhythm Clinical and Research Solutions, LLC
About this trial
This sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082).
Eligibility criteria
Qualifiers
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)
Disqualifiers
None
Trial design
Treatments tested in this trial
- Watchman FLX™ Pro device.
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Heart Rhythm Clinical and Research Solutions, LLC
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov