Adenosine vs AF Termination for Paroxysmal AF Ablation

September 10, 2014 updated by: Thomas Rostock, Johannes Gutenberg University Mainz

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • University Hospital Mainz, Department of Medicine II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • persistent AF
  • previous cardioversion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Adenosine testing after PVI and elimination of dormant conduction
Procedure: Adenosine test
Testing dormant conduction after PVI
Active Comparator: Group B - Termination of AF
Termination of atrial fibrillation by catheter ablation
Procedure: Termination of AF
Testing AF iducibility and ermination of

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arrhythmia-free survival
Time Frame: 1 year
arrhythmia-free outcome during 1 year after the procedure
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence if PV conduction after ablation in PVs with abolished dormant conduction
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Thomas Rostock, MD, University Hospital Mainz, Dept. of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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