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

May 23, 2022 updated by: Prof. Roland Richard Tilz, University of Luebeck
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • 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 Names:
  • Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Collaborators

IHF GmbH - Institut für Herzinfarktforschung

Investigators

  • Study Director: Roland Tilz, Prof. Dr., UKSH - Herzzentrum Lübeck - Section Electrophysiology
  • Principal Investigator: Christian Heeger, PD Dr., UKSH - Herzzentrum Lübeck - Section Electrophysiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2019

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-323

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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