Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
NCT07620262 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-07-17
Summary
This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.
Conditions
- Atrial Fibrillation (AF)
Interventions
- DEVICE
-
Remapping Procedure
Remapping procedure with LAAO Implant with or without additional ablation.
Sponsors & Collaborators
-
Boston Scientific Corporation
collaborator INDUSTRY -
Northwell Health
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2028-05-31
- Completion
- 2028-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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