Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
NCT07523620 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-05-27
Summary
The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.
Conditions
- Atrial Fibrillation (AF)
- Paroxysmal AF
- Persistent Atrial Fibrillation
Interventions
- PROCEDURE
-
PVI Ablation
PVI Ablation with Pulsed Field Ablation
- DEVICE
-
Left Atrial Appendage Occluder Implant
Left atrial appendage occluder implant
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2027-05-31
- Completion
- 2028-02-28
- FDA Device
- Yes
Countries
- Belgium
- Czechia
- Denmark
- Germany
- Ireland
- Italy
- Lithuania
- Poland
- Spain
Study Locations
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