Atrial Fibrillation Ablation: Radiofrequency or Cryoablation? (ARCFA)

May 13, 2019 updated by: Centre Hospitalier Régional Metz-Thionville

A Comparison of Radiofrequency Catheter Ablation With or Without Contact-force and Cryoablation for Paroxysmal Atrial Fibrillation Ablation

The study aims to compare 3 techniques routinely used for paroxysmal atrial fibrillation ablation: radiofrequency catheter ablation without contact-force, radiofrequency catheter ablation with contact-force and cryoablation. The hypothesis is the non-inferiority between the 3 techniques in terms of free-from atrial fibrillation survival (primary criteria). It will also compare lenght of procedure, radioscopy time and immediate complications (secondary criteria).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

206

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

  • France
    • Moselle
      • Metz, Moselle, France, 57085
        • CHR Metz Thionville

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had an atrial fibrillation for symptomatic paroxysmal atrial fibrillation, refractory to antiarrhythmic drugs, between 01/01/2014 and 30/09/2017 in CHR Metz-Thionville

Description

Inclusion Criteria:

  • Patients who had an atrial fibrillation for symptomatic paroxysmal atrial fibrillation, refractory to antiarrhythmic drugs, between 01/01/2014 and 30/09/2017 in CHR Metz-Thionville

Exclusion Criteria:

  • Patients not willing to participate via using their medical files

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial Fibrillation survival
Time Frame: Day 1
Free from atrial fibrillation survival
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate complications
Time Frame: Day 1
The number of immediate complications encountered
Day 1
Radioscopy duration
Time Frame: Day 1
Radioscopy duration
Day 1
Lenght of procedure
Time Frame: Day 1
Overall duration of the procedure
Day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Régional Metz-Thionville

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 (Actual)

January 25, 2019

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

December 12, 2018

First Posted (Actual)

December 13, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-05Obs-CHRMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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