Cryoablation of AF: Improving the Use of the Achieve Catheter

• Sponsor: Clinique Pasteur (Other)
• Overall Status: Completed
• CT.gov ID: NCT01843465
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Other: Maneuvers for documenting the disconnection

Study Design

• Study Type: Observational
• Actual Enrollment: 34 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Improving the Assessment of Pulmonary Vein Disconnection With the Achieve Catheter During Atrial Fibrillation Cryoablation
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Real-time Documentation of Pulmonary Vein Disconnection [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Pasteur	Toulouse	Haute-Garonne	France	31000

Sponsors and Collaborators

• Clinique Pasteur

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Serge Boveda, M.D., Clinique Pasteur
• ClinicalTrials.gov Identifier: NCT01843465
• Other Study ID Numbers: CP-CRYO-001
• First Posted: Apr 30, 2013
• Last Update Posted: Dec 13, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Serge Boveda, M.D., Clinique Pasteur: atrial fibrillation; balloon cryoablation; pulmonary veins
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	All patients were recruited at Clinique Pasteur. During the inclusion period, 36 underwent cryoballoon ablation of atrial fibrillation using the Achieve 20mm catheter for real-time documentation of PV potentials.
Pre-assignment Detail	2 patients were not considered eligible due to previous atrial fibrillation ablation.

Arm/Group Title	Cryoablation of Atrial Fibrillation
Arm/Group Description	All patients underwent cryoballoon ablation of atrial fibrillation using the Achieve 20mm catheter for real-time documentation of PV potentials. According to the maneuvers for documenting the disconnection , 4 PV types were defined: Type 1 - Achieve allowing documentation of PV disconnection in the standard position. Type 2 - Need of backward/proximal displacement of the Achieve catheter to display PV potentials during cryoenergy application. Type 3 - No possibility of clear documentation of PV potentials, but capture of PV with pacing Type 4 - no real-time documentation of PV disconnection
Period Title: Overall Study
STARTED	34
COMPLETED	34
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cryoablation of Atrial Fibrillation
Arm/Group Description	Maneuvers for documenting the disconnection :
Overall Participants	34
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	21 61.8%
>=65 years	13 38.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.5 (12.5)
Sex: Female, Male (Count of Participants)
Female	13 38.2%
Male	21 61.8%
Region of Enrollment (participants) [Number]
France	34 100%

Outcome Measures

1. Primary Outcome

Title	Real-time Documentation of Pulmonary Vein Disconnection
Description	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.
Time Frame	atrial fibrillation cryoablation procedure

Outcome Measure Data

Analysis Population Description

According to the different pulmonary vein anatomies in the study sample, 128 pulmonary veins were assessed.

Arm/Group Title	Cryoablation of Atrial Fibrillation
Arm/Group Description	Maneuvers for documenting the disconnection : Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins
Measure Participants	34
Measure pulmonary veins	128
Number [number of PVs disconnected in realtime]	125

Adverse Events

Arm/Group Title	Cryoablation of Atrial Fibrillation
Arm/Group Description	Maneuvers for documenting the disconnection : Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins
All Cause Mortality
	Cryoablation of Atrial Fibrillation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cryoablation of Atrial Fibrillation
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	Cryoablation of Atrial Fibrillation
	Affected / at Risk (%)	# Events
Total	2/34 (5.9%)
Cardiac disorders
atrial fibrillation of left atrial flutter recurrence in the first 24 hours	1/34 (2.9%)	1
Musculoskeletal and connective tissue disorders
phrenic nerve palsy lasting > 24 hours	1/34 (2.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.