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

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: Persistent or Long-standing Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Control intervention; Procedure: Experimental intervention

Detailed Description

The intervention in the LALA-LAND-AF trial is the additional LAAI in patients with catheter ablation for persistent AF and will be performed once as index ablation as outlined above. With exception of the index ablation, all patients will be treated according to the current clinical practice guidelines for AF as stated by the European Society of Cardiology (ESC) 11,18 and an expert consensus statement on catheter and surgical ablation1. Patients may be treated with a specific antiarrhythmic drug (AAD) for a maximum of 3 months following the index ablation. No repeat ablation for AF should be performed within the first 3 months. Thereafter, repeat ablations are permitted for recurrent AF irrespective of group allocation. Ablation strategy at repeat ablation includes PV re-isolation if required in both groups and re-isolation of the LAA in the intervention group. In the control group, LAAI may only be performed in case all PV were isolated.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roland Tilz, Prof. Dr.; Phone Number: 44672 +49451500; Email: roland.tilz@uksh.de
• Study Contact Backup: Name: Charlotte Eitel, Prof. Dr.; Phone Number: 44672 +49451500; Email: charlotte.eitel@uksh.de

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany
      • Contact: Roland Tilz, Prof. Dr.; Email: roland.tilz@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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 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

• 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

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028

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): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 19-323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No