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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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).
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 After AF ablation, the FARAWAVE Catheter will be withdrawn.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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| LAAC success and late-onset safety | 45-90 days leaks around LAAC device, 45-90 days device-related thrombus and | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural efficiency: | Number of transseptal crossings, Total procedure time of concomitant, Relative difference in procedure time of stand-alone PFA procedure timevs. concomitant PFA | 12 months |
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:
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
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Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| samantha S seepersad | Contact | 3525720027 | sseepersad@hrcrs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Institute at Grandview | Recruiting | Birmingham | Alabama | 35243 | United States |
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| Arrhythmia Center of South Florida | Recruiting | Delray Beach | Florida | 33484 | United States |
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| Ascension St. Vincent's Jacksonville | Not yet recruiting | Jacksonville | Florida | 32204 | United States |
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| HCA Research Institute- Mercy Hospital | Recruiting | Miami | Florida | 37203 | United States |
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| Ascension St Vincent -Indianapolis Ascension Health | Recruiting | Indianapolis | Indiana | 46184 | United States |
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| University of Iowa Hospitals and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Norton Heart & Vascular Institute | Not yet recruiting | Louisville | Kentucky | 40205 | United States |
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| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| Texas Cardiac Arrhythmia Research Foundation | Recruiting | Austin | Texas | 78705 | United States |
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| St, Mark's Hospital | Recruiting | Salt Lake City | Utah | 84124 | United States |
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| Chippenham Hospital) | Not yet recruiting | Richmond | Virginia | 23225 | United States |
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