Status:
COMPLETED
Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation
Lead Sponsor:
AZ Sint-Jan AV
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 pow...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04784013
Start Date
March 24 2021
End Date
May 31 2022
Last Update
June 21 2022
Active Locations (4)
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1
Medical University Hospital Graz
Graz, Austria
2
AZ Sint-Jan Brugge-Oostende AV
Bruges, Please Select, Belgium, 8000
3
UMC Leiden
Leiden, Netherlands
4
Luzerner Kantonsspital
Lucerne, Switzerland