Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04240366

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

Led by University of Luebeck · Updated on 2024-08-29

350

Participants Needed

3

Research Sites

450 weeks

Total Duration

On this page

Sponsors

U

University of Luebeck

Lead Sponsor

I

IHF GmbH - Institut für Herzinfarktforschung

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Persistent or long-standing persistent atrial fibrillation (continuous AF sustained >7 days or >12 months)
  • Age between 18 and 80 years
  • Indication for atrial fibrillation ablation according to current guidelines
Not Eligible

You will not qualify if you...

  • Missing informed consent
  • Left atrial appendage diameter greater than 25 mm measured 10 mm from the circumflex artery by TEE
  • Paroxysmal atrial fibrillation
  • Long-standing persistent atrial fibrillation with continuous duration over 4 years
  • Previous pulmonary vein isolation or MAZE surgery
  • Previous left atrial appendage closure or surgical excision
  • Left atrial diameter greater than 60 mm at baseline
  • Presence of left atrial thrombus at baseline

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University Hospital Eppendorf, Hamburg, Germany

Hamburg, Free and Hanseatic City of Hamburg, Germany, 20251

Actively Recruiting

2

Asklepios Klinik Altona

Hamburg, Free and Hanseatic City of Hamburg, Germany, 22763

Actively Recruiting

3

Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany

Lübeck, Schleswig-Holstein, Germany, 23538

Actively Recruiting

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Research Team

R

Roland Tilz, Prof. Dr.

CONTACT

C

Charlotte Eitel, Prof. Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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