Adenosine vs AF Termination for Paroxysmal AF Ablation

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: Adenosine test; Procedure: Termination of AF

Study type: Interventional

Funder types: Other

Identifiers

NCT02238392

1/2014

Details and patient eligibility

About

This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.

Full description

Despite intensive efforts to increase single procedure success rates of pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has not raised beyond 80%. This prospective, randomized study investigates the efficacy of two different procedural endpoints in terms of single-procedure arrhythmia-free outcome.

A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be randomized to two different treatment arms. In group-A patients, PVI will be performed with the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation will be continued by targeting extra-PV AF sources with the desired endpoint of termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to adenosine administration in the attempt to reveal and ablate dormant conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with paroxysmal AF
• de-novo AF ablation
• age > 18 years

Exclusion criteria

• persistent AF
• previous cardioversion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group A

Active Comparator group

Description:

Adenosine testing after PVI and elimination of dormant conduction

Treatment:

Procedure: Adenosine test

Group B - Termination of AF

Active Comparator group

Description:

Termination of atrial fibrillation by catheter ablation

Treatment:

Procedure: Termination of AF