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

NCT04240366 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Luebeck

Phase

Not applicable

Started

2019-12-17

Last updated

2024-08-29

Condition(s) studied

Persistent or Long-standing Persistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

Control interventionExperimental intervention

Control intervention: patients treated with balloon-based ablation of AF by PVI

Experimental intervention: patients treated with balloon-based ablation of AF by PVI

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \>7 days or \>12 months, respectively) 2. Age ≥18 and ≤80 years 3. Indication for AF ablation as per current guidelines Exclusion Criteria: 1. Missing informed consent 2. LAA diameter \>25mm 10mm distant from circumflex artery assessed by TEE 3. Paroxysmal atrial ﬁbrillation 4. Long-standing persistent atrial ﬁbrillation with a continuous AF duration of \>4 years 5. Previous pulmonary vein isolation or MAZE surgery 6. Previous led atrial appendage closure or surgical excision 7. Left atrial diameter \>60 mm at baseline 8. Left atrial thrombus at baseline

Primary outcome measure(s)

Time until any documented episode of ATa — 3 - 12 months
Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy

Trial sites (3)

Facility	City	Region	Status
University Hospital Eppendorf, Hamburg, Germany	Hamburg	Free and Hanseatic City of Hamburg	Recruiting
Asklepios Klinik Altona	Hamburg	Free and Hanseatic City of Hamburg	Recruiting
Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany	Lübeck	Schleswig-Holstein	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04240366 on ClinicalTrials.gov ↗ ← All trials in Germany