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OpenTrials
Completed

NCT Number: NCT01843465

Cryoablation of AF: Improving the Use of the Achieve Catheter

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Pasteur

Toulouse, Haute-Garonne, 31000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maneuvers for documenting the disconnection

Other

Other names: type 1, type 2, type 3, type 4

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 30, 2013
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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