Atrial Fibrillation Clinical Trial
— POWER_FASTOfficial title:
Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.
NCT number | NCT04162249 |
Other study ID # | PI-3271 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 15, 2017 |
Est. completion date | April 5, 2020 |
Verified date | September 2021 |
Source | Hospital Universitario La Paz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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: - Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall). - Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g. - Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g. The safety endpoint was evaluated with systematic esophageal endoscopy performed <72 h after the index procedure. The efficacy endpoint was evaluated: - during the ablation procedure: acute procedural efficacy, firts-pass isolation of ipsilateral pulmonary veins, total radiofrequency and procedural time, acute reconnections and dormant conduction, - during the follow-up: any atrial tachycardias documented and longer than 30 s were considered recurrences.
Status | Completed |
Enrollment | 78 |
Est. completion date | April 5, 2020 |
Est. primary completion date | April 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF. - Informed consent. Exclusion Criteria: - Previous surgical or catheter-based PVI. - Stroke or acute coronary syndrome <6 months before ablation. - Terminal comorbidities. - Frailty, or clinical instability. - Absolute contraindication for oral anticoagulation. |
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital La Paz, Department of Cardiology | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario La Paz |
Spain,
Castrejón-Castrejón S, Martínez Cossiani M, Ortega Molina M, Escobar C, Froilán Torres C, Gonzalo Bada N, Díaz de la Torre M, Suárez Parga JM, López Sendón JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical feasibility (systematic use of the high-power and short-duration technique) | Feasibility of the high-power and short-duration radiofrequency technique. | Intraprocedural. | |
Primary | Incidence of complications | Incidence of esophageal thermal lesiones. | < 72 hours after ablation. | |
Primary | Acute efficacy | Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction. | Intraprocedural | |
Primary | 1-year efficacy | Recurrence of atrial arrhythmias >30 seconds | One year | |
Secondary | Total radiofrequency time | Total radiofrequency time needed for definitive isolation of all pulmonary veins | Intraprocedural |
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