Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, balloon cryoablation, pulmonary veins
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.
Interventions
OTHERManeuvers for documenting the disconnection
Sponsors
Clinique Pasteur
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
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 details
2 patients were not considered eligible due to previous atrial fibrillation ablation.
Participants by arm
| Arm | Count |
|---|---|
| Cryoablation of Atrial Fibrillation Maneuvers for documenting the disconnection : | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Cryoablation of Atrial Fibrillation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age Continuous | 59.5 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment France | 34 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
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.
Time frame: atrial fibrillation cryoablation procedure
Population: According to the different pulmonary vein anatomies in the study sample, 128 pulmonary veins were assessed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation of Atrial Fibrillation | Real-time Documentation of Pulmonary Vein Disconnection | 125 number of PVs disconnected in realtime |