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Adenosine vs AF Termination for Paroxysmal AF Ablation

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Adenosine test
Termination of AF
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring paroxysmal atrial fibrillation, pulmonary vein isolation, adenosine, AF terminatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • persistent AF
  • previous cardioversion

Sites / Locations

  • University Hospital Mainz, Department of Medicine II

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B - Termination of AF

Arm Description

Adenosine testing after PVI and elimination of dormant conduction

Termination of atrial fibrillation by catheter ablation

Outcomes

Primary Outcome Measures

Arrhythmia-free survival
arrhythmia-free outcome during 1 year after the procedure

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2014
Last Updated
September 10, 2014
Sponsor
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT02238392
Brief Title
Adenosine vs AF Termination for Paroxysmal AF Ablation
Official Title
Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
paroxysmal atrial fibrillation, pulmonary vein isolation, adenosine, AF terminatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Adenosine testing after PVI and elimination of dormant conduction
Arm Title
Group B - Termination of AF
Arm Type
Active Comparator
Arm Description
Termination of atrial fibrillation by catheter ablation
Intervention Type
Procedure
Intervention Name(s)
Adenosine test
Intervention Description
Testing dormant conduction after PVI
Intervention Type
Procedure
Intervention Name(s)
Termination of AF
Intervention Description
Testing AF iducibility and ermination of
Primary Outcome Measure Information:
Title
Arrhythmia-free survival
Description
arrhythmia-free outcome during 1 year after the procedure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Recurrence if PV conduction after ablation in PVs with abolished dormant conduction
Description
PV conduction recurrences after elimination of dormant conduction. This endpoint will be evaluated during repeat procedures for recurrences of atrial fibrillation or atrial tachycardia.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with paroxysmal AF de-novo AF ablation age > 18 years Exclusion Criteria: persistent AF previous cardioversion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Rostock, MD
Organizational Affiliation
University Hospital Mainz, Dept. of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Mainz, Department of Medicine II
City
Mainz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26297786
Citation
Theis C, Konrad T, Mollnau H, Sonnenschein S, Kampfner D, Potstawa M, Ocete BQ, Bock K, Himmrich E, Munzel T, Rostock T. Arrhythmia Termination Versus Elimination of Dormant Pulmonary Vein Conduction as a Procedural End Point of Catheter Ablation for Paroxysmal Atrial Fibrillation: A Prospective Randomized Trial. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1080-7. doi: 10.1161/CIRCEP.115.002786. Epub 2015 Aug 21.
Results Reference
derived

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Adenosine vs AF Termination for Paroxysmal AF Ablation

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