PFA Ablation and LAAC Procedures
Conditions
Keywords
AF ablation, FARADRIVE™, Watchman FLX Pro
Brief summary
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).
Detailed 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 After AF ablation, the FARAWAVE Catheter will be withdrawn.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
Interventions
DEVICEWatchman FLX™ Pro device.
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
Sponsors
Heart Rhythm Clinical and Research Solutions, LLC
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of events between the time of implant and within 7 days following the procedure | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LAAC success and late-onset safety | 12 months | 45-90 days leaks around LAAC device, 45-90 days device-related thrombus and |
Countries
United States
Outcome results
None listed