Cryoablation of AF: Improving the Use of the Achieve Catheter

NCT01843465 | Completed Results

• 1 other identifier: CP-CRYO-001
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; balloon cryoablation; pulmonary veins

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cryoablation of atrial fibrillation

Other: Maneuvers for documenting the disconnection

Interventions

Maneuvers for documenting the disconnection OTHER

Also known as: type 1, type 2, type 3, type 4

Cryoablation of atrial fibrillation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinique Pasteur: lead

Study Sites (1)

Clinique Pasteur

Toulouse, Haute-Garonne, 31000, France

Location

Related Publications (1)

• Boveda S, Providencia R, Albenque JP, Combes N, Combes S, Hireche H, Casteigt B, Bouzeman A, Jourda F, Narayanan K, Marijon E. Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases? Europace. 2014 Jun;16(6):826-33. doi: 10.1093/europace/eut366. Epub 2013 Dec 18.

  PMID: 24351882 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Serge Boveda
• Organization: Clinique Pasteur, Toulouse, France

sboveda@clinique-pasteur.com

(33) 5 62 21 16 45

Study Officials

• Serge Boveda, M.D.

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 13, 2013
• Results First Posted: December 13, 2013

Record last verified: 2013-10

Locations

FR (1)