Cryoablation of AF: Improving the Use of the Achieve Catheter

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843465
• Other study ID #: CP-CRYO-001
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: October 18, 2013
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Clinique Pasteur
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Clinique Pasteur, Toulouse
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Maneuvers for documenting the disconnection

Locations

Country	Name	City	State
France	Clinique Pasteur	Toulouse	Haute-Garonne

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-time Documentation of Pulmonary Vein Disconnection	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	No