Status:
COMPLETED
Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation
Lead Sponsor:
AZ Sint-Jan AV
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atri...
Eligibility Criteria
Inclusion
- Patients between the ages of 18 and 85 years
- Diagnosed with symptomatic AF without previous mitral isthmus line ablation
Exclusion
- Previous MI line ablation
- Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
- LA diameter greater than 55 mm on long axis parasternal view, or left atrial volume more than 200 cc.
- Left ventricular ejection fraction \<35%.
- Cardiac surgery within the previous 90 days.
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
- Coronary PTCA/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
- Renal insufficiency
- Unstable angina.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation.
- Life expectancy less than 1 year.
- Uncontrolled heart failure.
- Presence of a condition that precludes vascular access.
- INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
- Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
- Unwilling or unable to provide informed consent.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04124328
Start Date
October 15 2019
End Date
March 1 2021
Last Update
August 3 2022
Active Locations (1)
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1
AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium, 8000