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Search / Trial NCT04240366

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

Launched by UNIVERSITY OF LUEBECK · Jan 23, 2020

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to treating a heart condition called persistent or long-standing persistent atrial fibrillation (AF), which is a type of irregular heartbeat that can lead to serious complications. The study is examining whether adding a procedure to isolate the left atrial appendage during a balloon ablation procedure can help reduce the chances of AF coming back within 3 to 12 months. Balloon ablation is a common treatment that targets specific areas in the heart to help restore a normal heartbeat.

To participate in this trial, you need to be between 18 and 80 years old and have persistent or long-standing persistent AF that has lasted for more than a week or a year, respectively. However, there are some reasons you might not be eligible, such as having certain heart conditions or previous surgeries related to AF. If you qualify and choose to participate, you can expect to receive careful monitoring and support throughout the study to see if this additional procedure makes a difference in your treatment. This trial is currently looking for participants, and it aims to provide more options for people struggling with this heart condition.

Gender

ALL

Eligibility criteria

  • 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

About University Of Luebeck

The University of Lübeck is a renowned academic institution in Germany, recognized for its commitment to advancing medical research and education. With a strong focus on innovative clinical trials, the university leverages its interdisciplinary expertise to explore novel therapeutic approaches and enhance patient care. The institution fosters collaboration among researchers, clinicians, and industry partners, ensuring a robust framework for conducting high-quality studies. Through its clinical trial initiatives, the University of Lübeck aims to translate scientific discoveries into tangible health solutions, contributing to the global advancement of medical knowledge and practices.

Locations

Hamburg, , Germany

Lübeck, Schleswig Holstein, Germany

Hamburg, , Germany

Patients applied

0 patients applied

Trial Officials

Roland R. Tilz, Prof. Dr.

Study Director

Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie

Sorin S. Popescu, MD

Study Chair

Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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