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Trial record 1 of 1 for:    LALA LAND
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Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation (LALA-LAND-AF)

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ClinicalTrials.gov Identifier: NCT04240366
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 24, 2022
Sponsor:
Collaborator:
IHF GmbH - Institut für Herzinfarktforschung
Information provided by (Responsible Party):
Prof. Roland Richard Tilz, University of Luebeck

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Persistent or Long-standing Persistent Atrial Fibrillation Procedure: Control intervention Procedure: Experimental intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Group 1
Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone
 Procedure: Control intervention
patients treated with balloon-based ablation of AF by PVI
Other Name: Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone
Experimental: Group 2
Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation
 Procedure: Experimental intervention
patients treated with balloon-based ablation of AF by PVI
Other Name: Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation


Outcome Measures
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Primary Outcome Measures :
  1. Time until any documented episode of ATa [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240366


Contacts
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Contact: Cornelia Wolf +49451500 ext 44672 Cornelia.Wolf@uksh.de

Locations
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Germany
Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Roland Tilz, Prof. Dr.       roland.tilz@uksh.de   
Sponsors and Collaborators
University of Luebeck
IHF GmbH - Institut für Herzinfarktforschung
Investigators
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Study Director: Roland Tilz, Prof. Dr. UKSH - Herzzentrum Lübeck - Section Electrophysiology
Principal Investigator: Christian Heeger, PD Dr. UKSH - Herzzentrum Lübeck - Section Electrophysiology
More Information
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Responsible Party: Prof. Roland Richard Tilz, Head of Electrophysiology Department, University of Luebeck
ClinicalTrials.gov Identifier: NCT04240366    
Other Study ID Numbers: 19-323
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes