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The POWER FAST I pilot study is a unicentric, observational, non-randomized controlled clinical study. In the control group pulmonary veins isolation was performded in consecutive patients with irrigated radiofrequency cateters without contact force-sensing capabilities and using conventional low-power and long-duration radiofrequency parameters (20-30 W, 30-60 s) under continuous intracardiac-echo image and esophageal temperature monitoring. The study group consist of consecutive patients distributed in three succesive subgroups. In the study group radiofrequency ablation was performed using a point-by-point technique with contact-force catheters with different high-power and short-duration parameters:
The safety endpoint was evaluated with systematic esophageal endoscopy performed <72 h after the index procedure. The efficacy endpoint was evaluated:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional ablation (CONTROL GROUP) | Pulmonary veins ablation.
Al procedures were performed with continuos intracardiac echo image and esophageal temperature monitoring. |
| |
| High-power and short-duration ablation | Pulmonary veins ablation.
Intracardiac echo was not used. Esophageal temperature probes were used only in 6 patients in the subgroup 50W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional LSI/AI-guided pulmonary veins ablation. | Other | Conventional (low-power and long-duration) radiofrequency application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical feasibility (systematic use of the high-power and short-duration technique) | Feasibility of the high-power and short-duration radiofrequency technique. | Intraprocedural. |
| Incidence of complications | Incidence of esophageal thermal lesiones. | < 72 hours after ablation. |
| Acute efficacy | Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction. | Intraprocedural |
| 1-year efficacy | Recurrence of atrial arrhythmias >30 seconds | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Total radiofrequency time | Total radiofrequency time needed for definitive isolation of all pulmonary veins | Intraprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive and unselected patients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital La Paz, Department of Cardiology | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31713704 | Result | Castrejon-Castrejon S, Martinez Cossiani M, Ortega Molina M, Escobar C, Froilan Torres C, Gonzalo Bada N, Diaz de la Torre M, Suarez Parga JM, Lopez Sendon JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radiofrequency application: short-term results of the POWER-FAST PILOT study. J Interv Card Electrophysiol. 2020 Jan;57(1):57-65. doi: 10.1007/s10840-019-00645-5. Epub 2019 Nov 12. |
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| High-power pulmonary veins ablation. | Other | Experimental (high-power and short-duration) radiofrequency application. |
|
| Esophageal temperature monitoring | Other | Two probes were simultaneously used: a deflectable one and a non-deflectable one. |
|
| Esophageal endoscopy | Diagnostic Test | Esophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation. |
|
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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