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

Persistent or Long-standing Persistent Atrial Fibrillation Clinical Trial

— LALA-LAND-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240366
• Other study ID #: 19-323
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: June 2025

Study information

• Verified date: May 2022
• Source: University of Luebeck
• Contact: Cornelia Wolf
• Phone: +49451500
• Email: Cornelia.Wolf[@]uksh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?brillation

4. Long-standing persistent atrial ?brillation 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent or Long-standing Persistent Atrial Fibrillation

Intervention

Procedure:
• Control intervention
patients treated with balloon-based ablation of AF by PVI
• Experimental intervention
patients treated with balloon-based ablation of AF by PVI

Locations

Country	Name	City	State
Germany	Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany	Lübeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	IHF GmbH - Institut für Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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