Comparing two methods of catheter ablation for atrial fibrillation
A Randomized Trial Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation
This study is testing whether a new method of catheter ablation can help people with persistent atrial fibrillation feel better compared to the standard approach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04101539 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of standard pulmonary vein isolation (PVI) compared to a new approach called OPTIMA-guided catheter ablation in patients with persistent atrial fibrillation. The research aims to improve outcomes for patients who have not responded well to traditional treatments. Participants will undergo a pre-operative cardiac MRI to assess left atrial scarring, which is crucial for determining eligibility. The study is being conducted at Johns Hopkins Hospital, a leading institution in cardiac care.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with persistent or long-standing persistent atrial fibrillation who are referred for catheter ablation.
Not a fit: Patients who are not suitable candidates for AF ablation or those with significant contraindications to anticoagulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ablation outcomes for patients with persistent atrial fibrillation.
How similar studies have performed: Previous studies have shown limited success with ancillary ablation techniques, making this approach novel in its focus on improving outcomes for persistent atrial fibrillation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: David Spragg, MD — Johns Hopkins University
- Study coordinator: David Spragg, MD
- Email: dspragg1@jhmi.edu
- Phone: 4105501973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.