Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
NCT ID: NCT04240366
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2019-12-17
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone
Control intervention
patients treated with balloon-based ablation of AF by PVI
Group 2
Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation
Experimental intervention
patients treated with balloon-based ablation of AF by PVI
Interventions
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Control intervention
patients treated with balloon-based ablation of AF by PVI
Experimental intervention
patients treated with balloon-based ablation of AF by PVI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 and ≤80 years
3. Indication for AF ablation as per current guidelines
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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IHF GmbH - Institut für Herzinfarktforschung
OTHER
University of Luebeck
OTHER
Responsible Party
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Roland Richard Tilz, MD
Head of Electrophysiology Department
Principal Investigators
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Roland R. Tilz, Prof. Dr.
Role: STUDY_DIRECTOR
Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
Sorin S. Popescu, MD
Role: STUDY_CHAIR
Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
Locations
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University Hospital Eppendorf, Hamburg, Germany
Hamburg, City state of Hamburg, Germany
Asklepios Klinik Altona
Hamburg, City state of Hamburg, Germany
Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany
Lübeck, Schleswig-Holstein, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-323
Identifier Type: -
Identifier Source: org_study_id
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