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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

This trial does not accept healthy volunteers

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 population

Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Watchman FLX™ Pro device.

    Device

    Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Combining LAAC and PFA ablation procedures1 intervention

Trial outcomes

Primary outcomes

1

The occurrence of events between the time of implant and within 7 days following the procedure

AF ablation safety will be compared between the concomitant procedures and standalone AF ablation cohort. and LAAC procedure safety will be compared between the concomitant procedures and standalone LAAC cohort.

Time frame
12 months

Secondary outcomes

1

LAAC success and late-onset safety

45-90 days leaks around LAAC device, 45-90 days device-related thrombus and

Time frame
12 months

Other outcomes

1

Procedural efficiency:

Number of transseptal crossings, Total procedure time of concomitant, Relative difference in procedure time of stand-alone PFA procedure timevs. concomitant PFA

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Rhythm Clinical and Research Solutions, LLC

Lead sponsor

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
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