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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation of atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maneuvers for documenting the disconnection | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients undergoing cryoablation of atrial fibrillation using the Achieve catheter to document pulmonary vein disconnection.
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| Name | Affiliation | Role |
|---|---|---|
| Serge Boveda, M.D. | Clinique Pasteur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur | Toulouse | Haute-Garonne | 31000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24351882 | Derived | 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. |
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2 patients were not considered eligible due to previous atrial fibrillation ablation.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cryoablation of Atrial Fibrillation | Maneuvers for documenting the disconnection : |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | According to the different pulmonary vein anatomies in the study sample, 128 pulmonary veins were assessed. | Posted | Number | number of PVs disconnected in realtime | atrial fibrillation cryoablation procedure | pulmonary veins | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryoablation of Atrial Fibrillation | Maneuvers for documenting the disconnection : Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| phrenic nerve palsy lasting > 24 hours | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Serge Boveda | Clinique Pasteur, Toulouse, France | (33) 5 62 21 16 45 | 8819 | sboveda@clinique-pasteur.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Maneuvers for documenting the disconnection :
Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins
|
|
| 0 |
| 34 |
| 2 |
| 34 |
| atrial fibrillation of left atrial flutter recurrence in the first 24 hours | Cardiac disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |