- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153747
High Radiofrequency Power for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III) (POWER-FAST)
High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)
Study Overview
Status
Conditions
Detailed Description
Multicenter 1:1 randomized study: Hospital Universitario La Paz, Madrid; Hospital Clínico Universitario San Carlos, Madrid; Hospital Clínico y Provincial de Barcelona, Barcelona; Complejo Hospitalario de Navarra, Pamplona; Hospital Clínico Universitario de Valladolid; Hospital Clínico Universitario de Albacete; Hospital Clínico Universitario de Alicante; Hospital Universitario Virgen de las Nieves, Granada; Hospital La Fe, Valencia; Hospital Clínico de Valencia; Hospital Universitario Juan Ramón Jiménez, Huelva; Hospital de la Ribera, Alzira, Valencia. España. Spain.
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 25-40 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).
Subestudy: asymptomatic cerebral lesions detected by 1,5 T MRI <72 h after ablation. Not all centers participate in the subestydy. However, if the center participates, all patients in both ablation groups will be included in the subestudy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid, Spain
- University Hospital La Paz, Department of Cardiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous pulmonary veins ablation of any type.
- Permanent atrial fibrillation or long-standing persistent AF (>1 year).
- 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.
- Persistent left atrial thrombus.
- Contraindication for anticoagulation.
- Absolute indication of double antiplatelet drugs.
- Complex congenital heart disease, corrected or not.
- Any clinical situation absolutely precluding an interventional procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional ablation
Point-by-point catheter-based pulmonary veins isolation using convencional radiofrequency parameters.
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Pulmonary veins electrical isolation: low-power ablation.
Esophageal endoscopy to detect postablation esophageal thermal lesions.
Transtelephonic daily 30-seconds single lead electrocardiogram
Other Names:
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Experimental: High-power and short-duration ablation
Point-by-point catheter-based pulmonary veins isolation using high-power and short duration radiofrequency: 70 W, duration per application 9-10 s (initial ramp 2-3 s according to the technical characterictics of radiofrequency sources), temperature limit 45 ºC, irrigation 17 ml/min, contac-force > 5 g.
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Esophageal endoscopy to detect postablation esophageal thermal lesions.
Transtelephonic daily 30-seconds single lead electrocardiogram
Other Names:
Pulmonary veins electrical isolation: high-power and short-duration ablation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: incidence of esophageal thermal lesions
Time Frame: 24 hours after ablation (permissible up to 72 hours after ablation)
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Incidence of thermal esophageal lesions evaluated by endoscopy
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24 hours after ablation (permissible up to 72 hours after ablation)
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Total radiofrequency time
Time Frame: during ablation procedure
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Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction).
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during ablation procedure
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Efficacy: recurrence of atrial arrhythmias
Time Frame: 1 year
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Recurrences of any atrial arrhythmias >30 seconds during 1-year follow-up evaluated by daily transtelephonic ECG transmissions (at least 1 ECG/day and additional transmissions whenever the patient perceives arrhythmia-related symptoms).
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: José L Merino, PhD, Hospital Universitario La Paz, Madrid, España.
- Study Chair: Sergio C Castrejón-Castrejón, PhD, Hospital Universitario La Paz, Madrid, España.
- Study Chair: Carlos Escobar Cervantes, PhD, Hospital Universitario La Paz, Madrid, España.
- Study Chair: Consuelo Froilán Torres, MD, Hospital Universitario La Paz, Madrid, España.
- Study Chair: Andrés Fernández Prieto, MD, Hospital Universitario La Paz, Madrid, España.
- Study Chair: Marcel Martínez Cossiani, MD, Hospital Universitario La Paz, Madrid, España.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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