Last updated: August 2, 2022
Sponsor: AZ Sint-Jan AV
Overall Status: Active - Recruiting
Phase
N/A
Condition
Cardiac Disease
Chest Pain
Arrhythmia
Treatment
N/AClinical Study ID
NCT04529785
2700
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients older than 18 years
- Patients scheduled for a repeat ablation of PAF after a previous PVI
- Confirmation of lasting pulmonary vein isolation at the time of randomization
Exclusion
Exclusion Criteria:
- Patients with persistent atrial fibrillation
- Previous ablation with isolation of the SVC, roofline, mitral line or previous vein ofMarshal ethanol infusion
- Left atrial thrombus. Left atrial appendage thrombus can be determined bypreprocedural 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 withchronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of theinvestigator 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.
- International Normalized Ratio greater than 3.5 within 24 hours of procedure - forpatients taking warfarin.
- Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
- Unwilling or unable to provide informed consent.
Study Design
Total Participants: 100
Study Start date:
September 11, 2020
Estimated Completion Date:
August 31, 2023
Connect with a study center
AZ Sint-Jan Brugge-Oostende AV
Brugge, Please Select 8000
BelgiumActive - Recruiting
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