Trial Outcomes & Findings for Cryoablation of AF: Improving the Use of the Achieve Catheter (NCT NCT01843465)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

34 participants

Primary outcome timeframe

atrial fibrillation cryoablation procedure

Results posted on

2013-12-13

Participant Flow

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.

2 patients were not considered eligible due to previous atrial fibrillation ablation.

Participant milestones

Participant milestones
Measure	Cryoablation of Atrial Fibrillation 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
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cryoablation of AF: Improving the Use of the Achieve Catheter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryoablation of Atrial Fibrillation n=34 Participants Maneuvers for documenting the disconnection :
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age Continuous	59.5 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment France	34 participants n=5 Participants

PRIMARY outcome

Timeframe: atrial fibrillation cryoablation procedure

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

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.

Outcome measures

Outcome measures
Measure	Cryoablation of Atrial Fibrillation n=128 pulmonary veins Maneuvers for documenting the disconnection : Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins
Real-time Documentation of Pulmonary Vein Disconnection	125 number of PVs disconnected in realtime

Adverse Events

Cryoablation of Atrial Fibrillation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cryoablation of Atrial Fibrillation n=34 participants at risk Maneuvers for documenting the disconnection : Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins
Musculoskeletal and connective tissue disorders phrenic nerve palsy lasting > 24 hours	2.9% 1/34 • Number of events 1
Cardiac disorders atrial fibrillation of left atrial flutter recurrence in the first 24 hours	2.9% 1/34 • Number of events 1

Additional Information

Dr Serge Boveda

Clinique Pasteur, Toulouse, France

Phone: (33) 5 62 21 16 45

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place