CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications
NCT ID: NCT04122963
Last Updated: 2021-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2019-02-15
2020-06-30
Brief Summary
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Detailed Description
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OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF.
POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High power group
The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).
High power CLOSE-guided PVI ablation
CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
Standard group
The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds)
Standard CLOSE-guided PVI ablation
Standard AF ablation according to the CLOSE-protocol
Interventions
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High power CLOSE-guided PVI ablation
CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
Standard CLOSE-guided PVI ablation
Standard AF ablation according to the CLOSE-protocol
Eligibility Criteria
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Inclusion Criteria
* Signed Patient Informed Consent Form
* Age 18 years or older
* Able and willing to comply with all follow-up testing and requirements
Exclusion Criteria
* Previous ablation for AF
* LA antero-posterior diameter\>50 mm (parasternal long axis view , PLAX)
* LVEF \<35% (ejection fraction)
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* CABG procedure within the last three months
* Awaiting cardiac transplantation or other cardiac surgery
* Documented left atrial thrombus on imaging
* Diagnosed atrial myxoma
* Women who are pregnant or breastfeeding
* Acute illness or active systemic infection or sepsis
* Unstable angina
* Uncontrolled heart failure
* Myocardial infarction within the previous two months
* History of blood clotting or bleeding abnormalities
* Contraindication to anticoagulation therapy (ie, heparin or warfarin)
* Life expectancy less than 12 months
* Enrollment in any other study evaluating another device or drug
* Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
18 Years
ALL
No
Sponsors
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AZ Sint-Jan AV
OTHER
Responsible Party
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Sebastien Knecht
Professor Doctor
Locations
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Department of Cardiology
Bruges, , Belgium
Countries
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References
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Wielandts JY, Kyriakopoulou M, Almorad A, Hilfiker G, Strisciuglio T, Phlips T, El Haddad M, Lycke M, Unger P, Le Polain de Waroux JB, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009112. doi: 10.1161/CIRCEP.120.009112. Epub 2020 Dec 10.
Other Identifiers
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2406
Identifier Type: -
Identifier Source: org_study_id
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