Clinical trial NCT04240366: Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Official title: Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent or Long-standing Persistent Atrial Fibrillation
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: IHF GmbH - Institut für Herzinfarktforschung
First posted: 2020-01-27
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time until any documented episode of ATa
timeFrame: 3 - 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: University Hospital Eppendorf, Hamburg, Germany
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
Study officials:
affiliation: Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
name: Roland R. Tilz, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
name: Sorin S. Popescu, MD
role: STUDY_CHAIR
References: