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NCT04162249: POWER_FAST
High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation - a Pilot Observational Study.
trial testing Conventional LSI/AI-guided pulmonary veins ablation. in Cardiac Arrhythmia in 78 participants. Completed in 5 April 2020.
5 April 2019
Quick facts
| Lead sponsor | Hospital Universitario La Paz |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 78 |
| Start date | 15 September 2017 |
| Primary completion | 5 April 2019 |
| Estimated completion | 5 April 2020 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Conventional LSI/AI-guided pulmonary veins ablation.
- High-power pulmonary veins ablation.
- Esophageal temperature monitoring
- Esophageal endoscopy
Conditions studied
- Cardiac Arrhythmia — all drugs for Cardiac Arrhythmia →
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Atrial Tachycardia — all drugs for Atrial Tachycardia →
- Esophagus Injury — all drugs for Esophagus Injury →
Sponsor
Hospital Universitario La Paz
Who can join
18 and older, any sex, with Cardiac Arrhythmia or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04162249
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hospital Universitario La Paz trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04162249 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitario La Paz
- Last refreshed: 14 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04162249.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing