Concomitant LAAC/AF Ablation (Watchman FLX Pro)

Heart Rhythm Clinical and Research Solutions (HRCRS)

Status: Enrolling

Conditions: PFA Ablation and LAAC Procedures

Treatments: Device: Watchman FLX™ Pro device.

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07041125

ALIGN-AF

Details and patient eligibility

About

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).

Full description

The prospective arm of the sub-study is intended to enroll 120 subjects indicated for PFA and Watchman in up to 20 US sites within the framework of the DISRUPT-AF registry. Subjects will be screened for eligibility to participate in concomitant PFA ablation for AF and LAAC by Watchman FLX Pro device in a single procedure. Both PVI and LAAC procedures are performed per SOC. In general, percutaneous catheterization will be initially established using FARADRIVE™ steerable sheath for ablation treatment of AF using the FARAWAVE Catheter per instruction for use (IFU) of the device and operator's standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. After AF ablation, the FARAWAVE Catheter will be withdrawn. The FARADRIVE™ steerable sheath will be replaced with Watchman FLX deployment sheath. Deployment of Watchman FLX Pro device to LAA to achieve LAAC will follow the standard practice of the care and IFU of the device. Patients will be followed up at 45-90 days for LAAC implant assessment and at 3, 6, and 12 months for arrhythmia recurrence assessment

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

120 participants in 1 patient group

Combining LAAC and PFA ablation procedures

Description:

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).

Treatment:

Device: Watchman FLX™ Pro device.