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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Luebeck

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control intervention

    Procedure/Surgery

    patients treated with balloon-based ablation of AF by PVI

  • Experimental intervention

    Procedure/Surgery

    patients treated with balloon-based ablation of AF by PVI

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Group 1Other 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

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

Time frame
3 - 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Luebeck

Lead sponsor

IHF GmbH - Institut für Herzinfarktforschung

Collaborator