RecruitingNot ApplicableNCT07523620

Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration

Sponsor

Abbott Medical Devices

Enrollment

240 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Persistent Atrial Fibrillation Paroxysmal AF

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Left Atrial Appendage Occluder Implant and a procedure called PVI Ablation for people with atrial fibrillation (af), paroxysmal af, and other related conditions. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPVI Ablation

PVI Ablation with Pulsed Field Ablation

DEVICELeft Atrial Appendage Occluder Implant

Left atrial appendage occluder implant

Locations(16)

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

Centralny Szpital Kliniczny Uniwersytetu

Lodz, Poland

Hospital de la Santa Creu I Sant Pau

Barcelona, Catalon, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Royal Sussex County Hospital

Brighton, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07523620

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