Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation (REDO-AF)

German Heart Center Munich

Status: Unknown

Conditions: Atrial Fibrillation; Recurrence

Treatments: Procedure: Linear ablation; Procedure: Ablation with stepwise approach

Study type: Interventional

Funder types: Other

Identifiers

NCT01229475

GER-EP-003

Details and patient eligibility

About

Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up.

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure.

The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure,
• with the last ablation procedure at least 3 months ago.
• at least one unsuccessful attempt of antiarrhythmic drug
• oral anticoagulation for at least 4 weeks prior to ablation

Exclusion criteria

• LA thrombus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Stepwise approach

Active Comparator group

Description:

Stepwise approach for repeat AF ablation

Treatment:

Procedure: Ablation with stepwise approach

Procedure: Linear ablation

Linear ablation

Active Comparator group

Description:

Linear ablation for repeat procedure in patients with recurrent atrial fibrillation

Treatment:

Procedure: Ablation with stepwise approach

Procedure: Linear ablation