Status:
COMPLETED
CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications
Lead Sponsor:
AZ Sint-Jan AV
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paro...
Detailed Description
BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) \>550 and \>400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to o...
Eligibility Criteria
Inclusion
- All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease
- Signed Patient Informed Consent Form
- Age 18 years or older
- Able and willing to comply with all follow-up testing and requirements
Exclusion
- Persistent atrial fibrillation (history of AF\>7days or history of cardioversion \> 48h of AF)
- 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
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04122963
Start Date
February 15 2019
End Date
June 30 2020
Last Update
February 12 2021
Active Locations (1)
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1
Department of Cardiology
Bruges, Belgium, 8000