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This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional group | Active Comparator |
| |
| 90W-group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional CLOSE-guided pulmonary vein isolation | Procedure | Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural time | Comparison of the procedural time (in minutes) between groups | Procedure (At time of ablation) |
| Measure | Description | Time Frame |
|---|---|---|
| Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation | Atrial tachyarrhythmia will be monitored by Holter | Months 4-6 after ablation |
| Radiofrequency (RF) ablation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mattias Duytschaever, MD, PhD | AZ Sint-Jan AV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Hospital Graz | Graz | Austria | ||||
| AZ Sint-Jan Brugge-Oostende AV |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36752467 | Derived | O'Neill L, El Haddad M, Berte B, Kobza R, Hilfiker G, Scherr D, Manninger M, Wijnmaalen AP, Trines SA, Wielandts JY, Gillis K, Lycke M, De Becker B, Tavernier R, Le Polain De Waroux JB, Knecht S, Duytschaever M. Very High-Power Ablation for Contiguous Pulmonary Vein Isolation: Results From the Randomized POWER PLUS Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):511-522. doi: 10.1016/j.jacep.2022.10.039. Epub 2023 Jan 18. |
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| High power short duration pulmonary vein isolation | Procedure | Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall. |
|
Comparison of the RF ablation time (in seconds) between groups
| Procedure (At time of ablation) |
| Fluoroscopy dose | Comparison of the fluoroscopy dose (Gy cm²) between groups | Procedure (At time of ablation) |
| First pass isolation rate | Reconnection of the veins after adenosine injection or waiting time | Procedure (At time of ablation) |
| Bruges |
| Please Select |
| 8000 |
| Belgium |
| UMC Leiden | Leiden | Netherlands |
| Luzerner Kantonsspital | Lucerne | Switzerland |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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