Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation

Launched by JOHNS HOPKINS UNIVERSITY · Sep 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches to a procedure called catheter ablation for patients with a heart condition known as atrial fibrillation (AF), particularly those with persistent AF. The researchers want to find out if adding a new technique called OPTIMA ablation to the standard method of pulmonary vein isolation (PVI) can improve patient outcomes. The goal is to see if this combined approach can help more patients stay free from AF and reduce the need for medications compared to using PVI alone.

To participate in the trial, patients must be at least 18 years old and have been referred for catheter ablation due to persistent or long-standing persistent AF. They should have already had a specific heart scan (MRI) that shows areas of scarring in the heart. Participants will be randomly assigned to either receive just the standard PVI treatment or the combination of PVI and OPTIMA ablation. Throughout the study, researchers will monitor the patients over the course of a year to evaluate how effective the treatment is and to check for any complications. This trial aims to enroll a total of 160 patients over four years.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.