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Atrial Fibrillation Ablation: Radiofrequency or Cryoablation? (ARCFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774550
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Brief Summary:
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).

Condition or disease
Atrial Fibrillation

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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Comparison of Radiofrequency Catheter Ablation With or Without Contact-force and Cryoablation for Paroxysmal Atrial Fibrillation Ablation
Actual Study Start Date : January 25, 2019
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Atrial Fibrillation survival [ Time Frame: Day 1 ]
    Free from atrial fibrillation survival


Secondary Outcome Measures :
  1. Immediate complications [ Time Frame: Day 1 ]
    The number of immediate complications encountered

  2. Radioscopy duration [ Time Frame: Day 1 ]
    Radioscopy duration

  3. Lenght of procedure [ Time Frame: Day 1 ]
    Overall duration of the procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774550


Locations
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France
CHR Metz Thionville
Metz, Moselle, France, 57085
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT03774550    
Other Study ID Numbers: 2018-05Obs-CHRMT
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional Metz-Thionville:
Atrial Fibrillation
Catheter ablation
Radiofrequency
Contact-force
Cryoablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes