NCT03774550

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 14, 2019

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

December 12, 2018

Last Update Submit

May 13, 2019

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationCatheter ablationRadiofrequencyContact-forceCryoablation

Outcome Measures

Primary Outcomes (1)

  • Atrial Fibrillation survival

    Free from atrial fibrillation survival

    Day 1

Secondary Outcomes (3)

  • Immediate complications

    Day 1

  • Radioscopy duration

    Day 1

  • Lenght of procedure

    Day 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patients not willing to participate via using their medical files

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz Thionville

Metz, Moselle, 57085, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 13, 2018

Study Start

January 25, 2019

Primary Completion

March 31, 2019

Study Completion

May 1, 2019

Last Updated

May 14, 2019

Record last verified: 2018-12

Locations

FR(1)