A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach

Johannes Gutenberg University (JGU)

Status and phase: Completed; Phase 4

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02654353

PersAF-Abl2014

Details and patient eligibility

About

This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.

Full description

A total number of 100 patients with persistent AF were randomized to receive either conventional stepwise ablation (conventional group) or a sequential substrate ablation (substrate group), both with the endpoint of AF termination. All patients were in AF before the procedure. The sequential substrate ablation consisted of pulmonary vein isolation (PVI) followed by cardioversion and linear ablation at the mitral isthmus, left atrial roof and cavotricuspid isthmus in order to modify the AF substrate. After achievement of bidirectional block, AF was re-induced and electrogram-based ablation was performed to achieve AF termination to sinus rhythm (SR). Endpoints are single-procedure outcome and total amount of RF ablation time required to terminate AF by electrogram-guided ablation.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• persistent atrial fibrillation lasting longer than 3 months
• no previous ablations
• at least 1 electrical cardioversion

Exclusion criteria

• non-persistent atrial fibrillation
• previous ablation procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A: stepwise ablation

Other group

Description:

Stepwise ablation of persistent atrial fibrillation (conventional treatment arm) In this arm, patients will be treated with the conventional stepwiese ablation approach

Treatment:

Procedure: Ablation

Group B: sequential substrate ablation

Active Comparator group

Description:

Sequential substrate ablation of persistent atrial fibrillation (novel procedure) In this arm, patients will undergo an ablation procedure that consist of PVI, cardioversion, linear ablation and atrial fibrillation re-induction after blocked lines, followed by electrogram-guided ablation

Treatment:

Procedure: Ablation