NCT02238392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

2.4 years

First QC Date

September 9, 2014

Last Update Submit

September 10, 2014

Conditions

Paroxysmal Atrial Fibrillation

Keywords

paroxysmal atrial fibrillationpulmonary vein isolationadenosineAF terminatin

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia-free survival

    arrhythmia-free outcome during 1 year after the procedure

    1 year

Secondary Outcomes (1)

  • Recurrence if PV conduction after ablation in PVs with abolished dormant conduction

    1 year

Study Arms (2)

Group A

ACTIVE COMPARATOR

Adenosine testing after PVI and elimination of dormant conduction

Procedure: Adenosine test

Group B - Termination of AF

ACTIVE COMPARATOR

Termination of atrial fibrillation by catheter ablation

Procedure: Termination of AF

Interventions

Adenosine testPROCEDURE

Testing dormant conduction after PVI

Group A
Termination of AFPROCEDURE

Testing AF iducibility and ermination of

Group B - Termination of AF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • persistent AF
  • previous cardioversion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Mainz, Department of Medicine II

Mainz, 55131, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26297786DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Rostock, MD

    University Hospital Mainz, Dept. of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thomas Rostock, MD

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 12, 2014

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

DE(1)