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RECRUITING
NCT07523620
NA

Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-03-31

Completion Date

2028-02-28

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

PROCEDURE

PVI Ablation

PVI Ablation with Pulsed Field Ablation

DEVICE

Left Atrial Appendage Occluder Implant

Left atrial appendage occluder implant

Locations (13)

UZ Brussel

Brussels, B CAP R, Belgium

Motol and Homolka University Hospital

Prague, Czech Republic, Czechia

Rigshospitalet

Copenhagen, Copenha, Denmark

Cardioangiologisches Centrum am Bethanien Krankenhaus

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schlesw, Germany

Deutsches Herzzentrum der Charite

Berlin, State of Berlin, Germany

Mater Private Hospital

Dublin, Dublin, Ireland

Centro Cardiologico Monzino

Milan, Italy, Italy

ASST Grande Ospedale Metropolitano

Milan, Lombard, Italy

Vilnius University Hospital Santaros Klinikos

Vilnius, Dzukija, Lithuania

Slaskie Centrum Chorob Serca

Zabrze, Silesian Voivodeship, Poland

Hospital de la Santa Creu I Sant Pau

Barcelona, Catalon, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain