Watchman FLX™ Pro device.
DevicePatients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
NCT Number: NCT07041125
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Arrhythmia Institute at Grandview, Birmingham, Alabama, United States
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 After AF ablation, the FARAWAVE Catheter will be withdrawn.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
Only the study team can determine whether someone qualifies for participation.
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
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
Time frame: 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.
Time frame: 12 months
45-90 days leaks around LAAC device, 45-90 days device-related thrombus and
Time frame: 12 months
Number of transseptal crossings, Total procedure time of concomitant, Relative difference in procedure time of stand-alone PFA procedure timevs. concomitant PFA
Heart Rhythm Clinical and Research Solutions, LLC
Other
Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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View Trial Details