Cryoablation of AF: Improving the Use of the Achieve Catheter

October 18, 2013 updated by: Serge Boveda, Clinique Pasteur

Improving the Assessment of Pulmonary Vein Disconnection With the Achieve Catheter During Atrial Fibrillation Cryoablation

According to data from high volume Centres, documentation of entry block with the Achieve catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to assess strategies using the Achieve catheter that can improve this performance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

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
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31000
        • Clinique Pasteur

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undergoing cryoablation of atrial fibrillation using the Achieve catheter to document pulmonary vein disconnection.

Description

Inclusion Criteria:

  • all consecutive patients undergoing atrial fibrillation cryoballoon ablation monitored with the Achieve catheter.

Exclusion Criteria:

  • patients in AF at the beginning of the procedure
  • patients with a previous AF ablation procedure

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cryoablation of atrial fibrillation
Other: Maneuvers for documenting the disconnection
Other Names:
  • type 1
  • type 2
  • type 3
  • type 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-time Documentation of Pulmonary Vein Disconnection
Time Frame: atrial fibrillation cryoablation procedure
Possibility of real-time documentation of the pulmonary vein during cryoballoon ablation, through the use of the Achieve catheter. This will be codified as "yes" or "no", and in case of an affirmative answer Final results will be expressed as a % of the total pulmonary veins where disconnection was documented in real-time and the time of maneuver of the Achieve catheter that was necessary i.e. standard position (type 1); withdrawal position (type 2) or need of pacing (type 3). A pulmonary vein where no real-time documentation is possible, will be named as a type 4.
atrial fibrillation cryoablation procedure

Collaborators and Investigators

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

Sponsor

Clinique Pasteur

Investigators

  • Principal Investigator: Serge Boveda, M.D., Clinique Pasteur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-CRYO-001

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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