Status:
COMPLETED
Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Atrial Fibrillation Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Catheter ablation is an established cornerstone of therapy for patients with symptomatic atrial fibrillation (AF) who wish to avoid anti-arrhythmic drug therapy or for whom anti-arrhythmics have prove...
Detailed Description
Background: Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia. Symptoms arising from AF are common, and may include palpitations, fatigue, exertional intolerance, and angin...
Eligibility Criteria
Inclusion
- Eligible patients must be at least 18 years old at the time of enrollment.
- Patient was referred to Johns Hopkins cardiac electrophysiology division for clinically indicated catheter ablation for persistent or long standing persistent AF either for index ablation or redo ablation.
- Patient is currently on systemic anticoagulation or has no contraindication to initiate systemic anticoagulation.
- Capable of undergoing informed consent.
- A Pre-Op cardiac MRI including LGE in sinus rhythm must be performed prior to ablation and patient should be capable of undergoing cardioversion and cardiac MRI.
- MRI scan should show evidence of left atrial scarring.
Exclusion
- Patient is not a suitable candidate for AF ablation.
- Patient is currently not on anticoagulation and has significant contraindications to initiate systemic anticoagulation.
- Pregnant women may not participate in the study because gadolinium MRI contrast is contraindicated in pregnancy.
- Patient with Body weight more than 300 lbs as they cannot undergo MRI scans.
- Patients with Glomerular Filtration Rate (GFR) \< 30 mL/min should not be enrolled in the study due to the use of intravenous gadolinium as an MRI contrast agent.
- No evidence of Left Arial fibrosis in MRI scan as these images are not suitable for simulation.
- Inability to get MRI in sinus rhythm.
- Long standing persistent AF more than 3 years of duration.
- Prior surgical maze procedure.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04101539
Start Date
September 1 2019
End Date
October 1 2025
Last Update
October 9 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287