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NCT03774550 Clinical Trial

Atrial Fibrillation Ablation: Radiofrequency or Cryoablation?

Atrial Fibrillation Clinical Trial

— ARCFA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03774550
Other study ID # 2018-05Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 25, 2019
Est. completion date May 1, 2019

Study information
Verified date December 2018
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 206
Est. completion date May 1, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHR Metz Thionville Metz Moselle

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Atrial Fibrillation survival Free from atrial fibrillation survival Day 1
Secondary Immediate complications The number of immediate complications encountered Day 1
Secondary Radioscopy duration Radioscopy duration Day 1
Secondary Lenght of procedure Overall duration of the procedure Day 1
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