Concomitant LAAC/AF Ablation (Watchman FLX Pro)

Conditions

• PFA Ablation and LAAC Procedures

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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).

Key Dates

Start date

Jun 1, 2025

Status verified

Sep 2025

Primary completion

Sep 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

120 participants (estimated)

Arms

• Arm: Combining LAAC and PFA ablation procedures
  AF ablation and LAAC procedures are performed per operators' standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. Both AF ablation and LAAC procedures may be performed with ICE or TEE. Assessment of LAAC peri-device leaks and device-related thrombi at 45-90 days may be performed with TEE or cardiac computed tomography angiography (CCTA).

Primary Outcome Measure

The occurrence of events between the time of implant and within 7 days following the procedure [ Time Frame: 12 months ]

Central Contacts

• samantha S seepersad
  3525720027
  [email protected]

Locations (11)

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