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NCT Number: NCT04240366

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asklepios Klinik Altona, Hamburg, Free and Hanseatic City of Hamburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Control intervention

Procedure

patients treated with balloon-based ablation of AF by PVI

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

Experimental intervention

Procedure

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

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Eitel, Prof. Dr.

CONTACT

[email protected]

+49451500 ext. 44672

Roland Tilz, Prof. Dr.

CONTACT

[email protected]

+49451500 ext. 44672

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • IHF GmbH - Institut für Herzinfarktforschung

Registry information

Acronym: LALA-LAND-AF

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2020
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.