Cardiac ArrhythmiaPOWER_FASTNCT04162249
High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation - a Pilot Observational Study.
An observational study of Cardiac Arrhythmia and Atrial Fibrillation, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia, Atrial Fibrillation, Atrial Tachycardia
- What is being tested?
- Conventional LSI/AI-guided pulmonary veins ablation., High-power pulmonary veins ablation. and Esophageal temperature monitoring
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2017to 5 Apr 2020
- Phase
- Observational
- 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
Study population: Consecutive and unselected patients.
Who may be able to join
- Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF.
- Informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.
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.
Read more
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.
- Being tested
- Conventional LSI/AI-guided pulmonary veins ablation., High-power pulmonary veins ablation., Esophageal temperature monitoring, Esophageal endoscopy
- Keywords
- Atrial fibrillation, Ablatión, High-power, Radiofrequency, Esophageal lesion
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional LSI/AI-guided pulmonary veins ablation.Other
Conventional (low-power and long-duration) radiofrequency application.
High-power pulmonary veins ablation.Other
Experimental (high-power and short-duration) radiofrequency application.
Esophageal temperature monitoringOther
Two probes were simultaneously used: a deflectable one and a non-deflectable one.
Esophageal endoscopyDiagnostic test
Esophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional ablation (CONTROL GROUP) | Pulmonary veins ablation.
* Anterior aspect: power 30 W, catheter dragging (30 s per point).
* Posterior aspect: point-by-point ablation using 30 W/30 s applications. If esophageal temperature measured with two independent esophageal probes exceeded 49 ºC radiofrequency settings were modified to 20 W/ 60 s and the number of radiofrequency applications minimized in areas with esophageal temperature rise.
Al procedures were performed with continuos intracardiac echo image and esophageal temperature monitoring. Receives: Other: Conventional LSI/AI-guided pulmonary veins ablation.; Other: Esophageal temperature monitoring; Diagnostic Test: Esophageal endoscopy | |
| High-power and short-duration ablation | Pulmonary veins ablation.
* 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.
Intracardiac echo was not used. Esophageal temperature probes were used only in 6 patients in the subgroup 50W. Receives: Other: High-power pulmonary veins ablation.; Diagnostic Test: Esophageal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical feasibility (systematic use of the high-power and short-duration technique)
Feasibility of the high-power and short-duration radiofrequency technique.
Measured: Intraprocedural.
Incidence of complications
Incidence of esophageal thermal lesiones.
Measured: < 72 hours after ablation.
Acute efficacy
Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.
Measured: Intraprocedural
1-year efficacy
Recurrence of atrial arrhythmias >30 seconds
Measured: One year
Secondary outcomes (1)
Total radiofrequency time
Total radiofrequency time needed for definitive isolation of all pulmonary veins
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start15 Sep 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2020
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 Cardiac ArrhythmiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162249
- Sponsor's protocol ID
- PI-3271
- Acronym
- POWER_FAST
- Status last verified
- Sep 2021
- First submitted
- 11 Nov 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castrejon-Castrejon S, Martinez Cossiani M, Ortega Molina M, Escobar C, Froilan Torres C, Gonzalo Bada N, Diaz de la Torre M, Suarez Parga JM, Lopez Sendon JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radiofrequency application: short-term results of the POWER-FAST PILOT study. J Interv Card Electrophysiol. 2020 Jan;57(1):57-65. doi: 10.1007/s10840-019-00645-5. Epub 2019 Nov 12.
PubMed 31713704
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.
- ClinicalTrials.gov ID
- NCT04162249
- Acronym / sponsor ID
- POWER_FAST / PI-3271
- Keywords
- Atrial fibrillation, Ablatión, High-power, Radiofrequency, Esophageal lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 14 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ablation (CONTROL GROUP) | – | Other: Conventional LSI/AI-guided pulmonary veins ablation., Other: Esophageal temperature monitoring, Diagnostic Test: Esophageal endoscopyPulmonary veins ablation. * Anterior aspect: power 30 W, catheter dragging (30 s per point). * Posterior aspect: point-by-point ablation using 30 W/30 s applications. If esophageal temperature measured with two independent esophageal probes exceeded 49 ºC radiofrequency settings were modified to 20 W/ 60 s and the number of radiofrequency applications minimized in areas with esophageal temperature rise. Al procedures were performed with continuos intracardiac echo image and esophageal temperature monitoring. |
| High-power and short-duration ablation | – | Other: High-power pulmonary veins ablation., Diagnostic Test: Esophageal endoscopyPulmonary veins ablation. * 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. Intracardiac echo was not used. Esophageal temperature probes were used only in 6 patients in the subgroup 50W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive and unselected patients.
Key inclusion criteria (2 listed)
- Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF.
- Informed consent.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Conventional LSI/AI-guided pulmonary veins ablation.Conventional (low-power and long-duration) radiofrequency application. | Other | Conventional ablation (CONTROL GROUP) |
| High-power pulmonary veins ablation.Experimental (high-power and short-duration) radiofrequency application. | Other | High-power and short-duration ablation |
| Esophageal temperature monitoringTwo probes were simultaneously used: a deflectable one and a non-deflectable one. | Other | Conventional ablation (CONTROL GROUP) |
| Esophageal endoscopyEsophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation. | Diagnostic test | Conventional ablation (CONTROL GROUP), High-power and short-duration ablation |
Primary outcome
Clinical feasibility (systematic use of the high-power and short-duration technique)
Time frame: Intraprocedural.
Feasibility of the high-power and short-duration radiofrequency technique.
Incidence of complications
Time frame: < 72 hours after ablation.
Incidence of esophageal thermal lesiones.
Acute efficacy
Time frame: Intraprocedural
Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.
1-year efficacy
Time frame: One year
Recurrence of atrial arrhythmias >30 seconds
1 secondary outcome
Total radiofrequency time
Time frame: Intraprocedural
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 14 Sep 2021.
- Results publication: PubMed 31713704Castrejon-Castrejon S, Martinez Cossiani M, Ortega Molina M, Escobar C, Froilan Torres C, Gonzalo Bada N, Diaz de la Torre M, Suarez Parga JM, Lopez Sendon JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radiofrequency application: short-term results of the POWER-FAST PILOT study. J Interv Card Electrophysiol. 2020 Jan;57(1):57-65. doi: 10.1007/s10840-019-00645-5. Epub 2019 Nov 12.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia and Atrial Fibrillation, 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 2 inclusion and 5 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 14 Sep 2021. 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?
Clinical feasibility (systematic use of the high-power and short-duration technique) (time frame: Intraprocedural.). The study lists 4 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 NCT04162249, 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 14 Sep 2021.