A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation
Sponsor: Biosense Webster, Inc. • ClinicalTrials.gov ID: NCT07527299
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The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \[PVI\] and superior vena cava isolation \[SVCI\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.
Interventions
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VARIPULSE Catheter System
(Device)
Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.
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LAAO Device
(Device)
LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).
Eligibility criteria
Conditions
Locations
- Grandview Medical Center — Birmingham, Alabama, United States
- Pima Heart and Vascular — Tucson, Arizona, United States
- Arrhythmia Research Group — Jonesboro, Arkansas, United States
- Pacific Heart Institute Cedars Sinai Medical Center — Santa Monica, California, United States
- Aurora Denver Cardiology Associates — Aurora, Colorado, United States
- Hartford Hospital — Hartford, Connecticut, United States
- Saint Elizabeth Medical Center — Edgewood, Kentucky, United States
- Albert Einstein College Of Medicine - Montefiore Medical Center — The Bronx, New York, United States
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
- Mercy Hospital — Janesville, Wisconsin, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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