Adenosine vs AF Termination for Paroxysmal AF Ablation

Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02238392

Enrollment

150

Registered

2014-09-12

Start date

2012-01-31

Completion date

2014-06-30

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Keywords

paroxysmal atrial fibrillation, pulmonary vein isolation, adenosine, AF terminatin

Brief summary

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

Detailed 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.

Interventions

PROCEDUREAdenosine test

Testing dormant conduction after PVI

PROCEDURETermination of AF

Testing AF iducibility and ermination of

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* persistent AF * previous cardioversion

Design outcomes

Primary

Measure	Time frame	Description
Arrhythmia-free survival	1 year	arrhythmia-free outcome during 1 year after the procedure

Secondary

Measure	Time frame	Description
Recurrence if PV conduction after ablation in PVs with abolished dormant conduction	1 year	PV conduction recurrences after elimination of dormant conduction. This endpoint will be evaluated during repeat procedures for recurrences of atrial fibrillation or atrial tachycardia.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026