- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04784013
Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation (POWER-PLUS)
June 17, 2022 updated by: Prof. Dr. Mattias Duytschaever, AZ Sint-Jan AV
Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study
This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
182
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria
- Medical University Hospital Graz
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Please Select
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Brugge, Please Select, Belgium, 8000
- AZ Sint-Jan Brugge-Oostende AV
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Leiden, Netherlands
- UMC Leiden
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Luzern, Switzerland
- Luzerner Kantonsspital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients older than 18 years
- Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or <7days) or persistent AF (persistent AF is defined as having an AF episode >7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial)
- Patients willing to sign informed consent
Exclusion Criteria:
- Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode >1yr)
- Previous ablation for AF
- Left atrium antero-posterior diameter >50 mm (parasternal long axis view, PLAX)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
- Left ventricular ejection fraction <35%.
- Cardiac surgery within the previous 90 days.
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
- Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
- Documented history of a thromboembolic event within the previous 90 days.
- Diagnosed atrial myxoma.
- Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- Women who are pregnant or who plan to become pregnant during the study.
- Acute illness or active infection at time of index procedure
- Advanced renal insufficiency
- Unstable angina.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation.
- Life expectancy less than 1 year.
- Presence of a condition that precludes vascular access.
- Unwilling or unable to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
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Active Comparator: Conventional group
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Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins.
RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min).
RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall.
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Active Comparator: 90W-group
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Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins.
RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min).
RF will be delivered for 4 sec at both the posterior and anterior wall.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Procedural time
Time Frame: Procedure (At time of ablation)
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Comparison of the procedural time (in minutes) between groups
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Procedure (At time of ablation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation
Time Frame: Months 4-6 after ablation
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Atrial tachyarrhythmia will be monitored by Holter
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Months 4-6 after ablation
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Radiofrequency (RF) ablation time
Time Frame: Procedure (At time of ablation)
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Comparison of the RF ablation time (in seconds) between groups
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Procedure (At time of ablation)
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Fluoroscopy dose
Time Frame: Procedure (At time of ablation)
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Comparison of the fluoroscopy dose (Gy cm²) between groups
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Procedure (At time of ablation)
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First pass isolation rate
Time Frame: Procedure (At time of ablation)
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Reconnection of the veins after adenosine injection or waiting time
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Procedure (At time of ablation)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mattias Duytschaever, MD, PhD, AZ Sint-Jan AV
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 24, 2021
Primary Completion (Actual)
October 22, 2021
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
March 4, 2021
First Posted (Actual)
March 5, 2021
Study Record Updates
Last Update Posted (Actual)
June 21, 2022
Last Update Submitted That Met QC Criteria
June 17, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2800
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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