Atrial FibrillationPOWER-FASTNCT04153747
High Radiofrequency Power for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III)
A study testing High-power and short-duration radiofrequency ablatio (70 W / 9-10 s), Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values and Esophageal endoscopy in people with Atrial Fibrillation and Catheter Ablation, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Catheter Ablation
- What is being tested?
- High-power and short-duration radiofrequency ablatio (70 W / 9-10 s), Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values and Esophageal endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteSpain
- Study dates
- 25 Apr 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)
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).
Read the 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.
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Being tested
- High-power and short-duration radiofrequency ablatio (70 W / 9-10 s), Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values, Esophageal endoscopy, Daily 30-seconds ECG
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)Other
Pulmonary veins electrical isolation: high-power and short-duration ablation
Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) valuesOther
Pulmonary veins electrical isolation: low-power ablation.
Esophageal endoscopyOther
Esophageal endoscopy to detect postablation esophageal thermal lesions.
Daily 30-seconds ECGDiagnostic test
Also called Transtelephonic daily 30-seconds single lead electrocardiogram
Transtelephonic daily 30-seconds single lead electrocardiogram
| Study group | Role | What they receive |
|---|---|---|
| Conventional ablation | Active comparator | Point-by-point catheter-based pulmonary veins isolation using convencional radiofrequency parameters.
* Anterior aspect of pulmonary veins: 40 W, temperature limit 45 ºC, irrigation 17-30 ml/min; objective LSI>=6 or Ablation index >=500.
* Posterior aspect of pulmonary veins: 20-40 W, temperature limit 45 ºC, irrigation 17-3 ml/min; objective LSI>=5 or Ablation index >=350. Receives: Other: Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values; Other: Esophageal endoscopy; Diagnostic Test: Daily 30-seconds ECG |
| High-power and short-duration ablation | Experimental | 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. Receives: Other: High-power and short-duration radiofrequency ablatio (70 W / 9-10 s); Other: Esophageal endoscopy; Diagnostic Test: Daily 30-seconds ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: incidence of esophageal thermal lesions
Incidence of thermal esophageal lesions evaluated by endoscopy
Measured: 24 hours after ablation (permissible up to 72 hours after ablation)
Efficacy: recurrence of atrial arrhythmias
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).
Measured: 1 year
Total radiofrequency time
Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction).
Measured: during ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start25 Apr 2019
- Primary completion30 Apr 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sergio Castrejón-Castrejón, Hospital Universitario La Paz
- Investigators
- José L Merino, PhD, Principal investigator, Hospital Universitario La Paz, Madrid, España.Sergio C Castrejón-Castrejón, PhD, Study chair, Hospital Universitario La Paz, Madrid, España.Carlos Escobar Cervantes, PhD, Study chair, Hospital Universitario La Paz, Madrid, España.Consuelo Froilán Torres, MD, Study chair, Hospital Universitario La Paz, Madrid, España.Andrés Fernández Prieto, MD, Study chair, Hospital Universitario La Paz, Madrid, España.Marcel Martínez Cossiani, MD, Study chair, Hospital Universitario La Paz, Madrid, España.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153747
- Sponsor's protocol ID
- 5064
- Acronym
- POWER-FAST
- Status last verified
- Jan 2024
- First submitted
- 2 Nov 2019
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castrejon-Castrejon S, Martinez Cossiani M, Basterra Sola N, Romero Roldan JD, Ibanez Criado JL, Osca J, Roca-Luque I, Moya A, Quesada A, Hidalgo Olivares VM, Perez Castellano N, Fernandez-Gomez JM, Macias-Ruiz R, Villanueva BB, Gonzalo Bada N, Froilan Torres C, Sanz Verdejo B, Sanchez Somonte P, Escobar Cervantes C, Moreno R, Merino JL; POWER FAST III Trial Investigators. High-Power Short-Duration Radiofrequency Application for Faster and Safer Pulmonary Vein Isolation: The POWER-FAST III Trial. JACC Clin Electrophysiol. 2025 Feb;11(2):350-361. doi: 10.1016/j.jacep.2024.10.009. Epub 2024 Dec 18.
PubMed 39708035
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)
- ClinicalTrials.gov ID
- NCT04153747
- Acronym / sponsor ID
- POWER-FAST / 5064
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ablation | Active comparator | Other: Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values, Other: Esophageal endoscopy, Diagnostic Test: Daily 30-seconds ECGPoint-by-point catheter-based pulmonary veins isolation using convencional radiofrequency parameters. * Anterior aspect of pulmonary veins: 40 W, temperature limit 45 ºC, irrigation 17-30 ml/min; objective LSI>=6 or Ablation index >=500. * Posterior aspect of pulmonary veins: 20-40 W, temperature limit 45 ºC, irrigation 17-3 ml/min; objective LSI>=5 or Ablation index >=350. |
| High-power and short-duration ablation | Experimental | Other: High-power and short-duration radiofrequency ablatio (70 W / 9-10 s), Other: Esophageal endoscopy, Diagnostic Test: Daily 30-seconds ECGPoint-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)Pulmonary veins electrical isolation: high-power and short-duration ablation | Other | High-power and short-duration ablation |
| Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) valuesPulmonary veins electrical isolation: low-power ablation. | Other | Conventional ablation |
| Esophageal endoscopyEsophageal endoscopy to detect postablation esophageal thermal lesions. | Other | Conventional ablation, High-power and short-duration ablation |
| Daily 30-seconds ECGAlso: Transtelephonic daily 30-seconds single lead electrocardiogramTranstelephonic daily 30-seconds single lead electrocardiogram | Diagnostic test | Conventional ablation, High-power and short-duration ablation |
Primary outcome
Safety: incidence of esophageal thermal lesions
Time frame: 24 hours after ablation (permissible up to 72 hours after ablation)
Incidence of thermal esophageal lesions evaluated by endoscopy
Efficacy: recurrence of atrial arrhythmias
Time frame: 1 year
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).
Total radiofrequency time
Time frame: during ablation procedure
Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 39708035Castrejon-Castrejon S, Martinez Cossiani M, Basterra Sola N, Romero Roldan JD, Ibanez Criado JL, Osca J, Roca-Luque I, Moya A, Quesada A, Hidalgo Olivares VM, Perez Castellano N, Fernandez-Gomez JM, Macias-Ruiz R, Villanueva BB, Gonzalo Bada N, Froilan Torres C, Sanz Verdejo B, Sanchez Somonte P, Escobar Cervantes C, Moreno R, Merino JL; POWER FAST III Trial Investigators. High-Power Short-Duration Radiofrequency Application for Faster and Safer Pulmonary Vein Isolation: The POWER-FAST III Trial. JACC Clin Electrophysiol. 2025 Feb;11(2):350-361. doi: 10.1016/j.jacep.2024.10.009. Epub 2024 Dec 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José L Merino, PhD principal investigator
Hospital Universitario La Paz, Madrid, España.
Sergio C Castrejón-Castrejón, PhD study chair
Hospital Universitario La Paz, Madrid, España.
Carlos Escobar Cervantes, PhD study chair
Hospital Universitario La Paz, Madrid, España.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-power and short-duration radiofrequency ablatio (70 W / 9-10 s), Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values and Esophageal endoscopy in people with Atrial Fibrillation and Catheter Ablation, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: incidence of esophageal thermal lesions (time frame: 24 hours after ablation (permissible up to 72 hours after ablation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.