NCT01918670

Brief Summary

Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a procedure that is currently used for the treatment of symptomatic atrial fibrillation patients. We have organized a multi-centric national survey of catheter ablation of atrial fibrillation in order to have a feedback on the type of procedures being performed and the overall results (freedom of atrial fibrillation) over an average follow-up of 18 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 8, 2013

Status Verified

August 1, 2013

Enrollment Period

2.7 years

First QC Date

August 6, 2013

Last Update Submit

August 6, 2013

Conditions

Keywords

atrial fibrillation; catheter ablation; relapse; stroke; death

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation relapse

    Documentation of atrial fibrillation relapse (symptomatic or asymptomatic) after the first 3 months after the index procedure

    starting 3 months after the procedure till an average of 18months follow-up

Secondary Outcomes (1)

  • Early atrial fibrillation relapse

    first 3 months

Study Arms (6)

Pasteur

Procedure: catheter ablation of atrial fibrillation

Grenoble

Procedure: catheter ablation of atrial fibrillation

Nantes

Procedure: catheter ablation of atrial fibrillation

Parly

Procedure: catheter ablation of atrial fibrillation

Rennes

Procedure: catheter ablation of atrial fibrillation

Rouen

Procedure: catheter ablation of atrial fibrillation

Interventions

electric pulmonary vein disconnection

GrenobleNantesParlyPasteurRennesRouen

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing catheter ablation in one of the registry centers

You may qualify if:

  • all patients undergoing catheter ablation of atrial fibrillation or left atrial flutter

You may not qualify if:

  • patients undergoing catheter ablation of other types of arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Pasteur

Toulouse, France

Location

MeSH Terms

Conditions

Atrial FibrillationRecurrenceStrokeDeath

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 8, 2013

Study Start

November 1, 2010

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

August 8, 2013

Record last verified: 2013-08

Locations