Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240366
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
IHF GmbH - Institut für Herzinfarktforschung
Information provided by (Responsible Party):
Prof. Roland Richard Tilz, University of Luebeck

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 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 : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  4. Indication for LAA closure 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

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
Layout table for location contacts
Contact: Roland Tilz, Prof. roland.tilz@uksh.de
Contact: Roza Meyer-Saraei, PhD 004945150044542 roza.meyer-saraei@uksh.de

Locations
Layout table for location information
Germany
Medical clinic II-UKSH Luebeck, Schleswig-Holstein Germany Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Roland Tilz, Prof. Dr. med.       roland.tilz@uksh.de   
Sponsors and Collaborators
University of Luebeck
IHF GmbH - Institut für Herzinfarktforschung
Layout table for additonal information
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: January 27, 2020
Last Verified: January 2020

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