RecruitingNot ApplicableNCT04240366

Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation


Sponsor

University of Luebeck

Enrollment

350 participants

Start Date

Dec 17, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding isolation of the left atrial appendage (a small pouch in the heart) during a balloon-based heart ablation procedure improves outcomes for patients with persistent or long-standing atrial fibrillation (an irregular heart rhythm). **You may be eligible if...** - You are between 18 and 80 years old - You have persistent or long-standing persistent atrial fibrillation (AF that has lasted more than 7 days, or more than 12 months) - Your doctor has recommended ablation treatment for your atrial fibrillation - Your left atrial appendage is of appropriate size and your atrium is not overly enlarged **You may NOT be eligible if...** - You have paroxysmal atrial fibrillation (comes and goes on its own) - Your AF has been continuous for more than 4 years - You have had a prior ablation procedure or MAZE surgery for AF - You have had a prior left atrial appendage closure procedure or surgical removal - You have a blood clot in your atrium - Your left atrium is very large (greater than 60 mm) Talk to your doctor to see if this trial is right for you.

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

PROCEDUREControl intervention

patients treated with balloon-based ablation of AF by PVI

PROCEDUREExperimental intervention

patients treated with balloon-based ablation of AF by PVI


Locations(3)

University Hospital Eppendorf, Hamburg, Germany

Hamburg, Free and Hanseatic City of Hamburg, Germany

Asklepios Klinik Altona

Hamburg, Free and Hanseatic City of Hamburg, Germany

Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany

Lübeck, Schleswig-Holstein, Germany

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NCT04240366