NCT04153747Completed
High Radiofrequency Power for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III)
High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)
Source: ClinicalTrials.gov · Last updated 10 Jan 2024
Brief summary (registry, in English)
Multicenter 1:1 randomized study. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI \> 6 or AI \> 500 on the anterior aspect of pulmonary veins and power 25 W guided by LSI \>5 or AI \>350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 304 (actual)
- First submitted
- 2 Nov 2019
- Start date
- 25 Apr 2019
- Primary completion date
- 30 Apr 2023
- Lead sponsor
- Hospital Universitario La Paz
- Diseases
- Atrial fibrillation
- NCT number
- NCT04153747
What you commit to
- Study type: Interventional
- Participants enrolled: 304
- From 25 Apr 2019 to the primary completion date, 30 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pulmonary veins ablation of any type.
- Heart surgery \<3 months before ablation.
- Coronary revascularization of any type \<3 months before ablation.
- Myocardial infarction or acute coronary syndrome \< 3 months before ablation.
- Stroke or transient cerebral ischaemic attack \< 3 months before ablation.
- Absolute indication of double antiplatelet drugs.
Other illness
- Complex congenital heart disease, corrected or not.
Other
- Permanent atrial fibrillation or long-standing persistent AF (\>1 year).
- Persistent left atrial thrombus.
- Contraindication for anticoagulation.
- Any clinical situation absolutely precluding an interventional procedure.
Who the study is looking for
- Paroxysmal or persistent atrial fibrillation.
- Currently accepted class I or II indication for ablation according to practice guidelines: symptomatic arrhythmia, failure of at least 1 antiarrhythmic drug or patient's manifest preference of ablation instead of drugs.
- Age \> 18 years.
- Acceptance of informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital La Paz, Department of Cardiology Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.