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

NCT04240366 | Recruiting DMC

• 1 other identifier: 19-323
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 3

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.

Conditions

Persistent or Long-standing Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Time until any documented episode of ATa

  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

Study Arms (2)

Group 1

OTHER

Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone

Procedure: Control intervention

Group 2

EXPERIMENTAL

Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation

Procedure: Experimental intervention

Interventions

Control intervention PROCEDURE

patients treated with balloon-based ablation of AF by PVI

Also known as: Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone

Group 1

Experimental intervention PROCEDURE

patients treated with balloon-based ablation of AF by PVI

Also known as: Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \>7 days or \>12 months, respectively)
• Age ≥18 and ≤80 years
• Indication for AF ablation as per current guidelines

You may not qualify if:

• Missing informed consent
• LAA diameter \>25mm 10mm distant from circumflex artery assessed by TEE
• Paroxysmal atrial fibrillation
• Long-standing persistent atrial fibrillation with a continuous AF duration of \>4 years
• Previous pulmonary vein isolation or MAZE surgery
• Previous led atrial appendage closure or surgical excision
• Left atrial diameter \>60 mm at baseline
• Left atrial thrombus at baseline

Sponsors & Collaborators

• University of Luebeck: lead
• IHF GmbH - Institut für Herzinfarktforschung: collaborator

Study Sites (3)

University Hospital Eppendorf, Hamburg, Germany

Hamburg, Hamburg, 20251, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, Hamburg, 22763, Germany

RECRUITING

Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Study Officials

• Roland R. Tilz, Prof. Dr.

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

  STUDY DIRECTOR

• Sorin S. Popescu, MD

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

  STUDY CHAIR

Central Study Contacts

Roland Tilz, Prof. Dr.

CONTACT

+49451500; roland.tilz@uksh.de

Charlotte Eitel, Prof. Dr.

CONTACT

+49451500; charlotte.eitel@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Electrophysiology Department

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 27, 2020
• Study Start: December 17, 2019
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)