Your session is about to expire
← Back to Search
Procedure
Imaging-Guided Ablation for Cardiovascular Disease (STABLE-VT Trial)
N/A
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new method for treating abnormal heart rhythms by using advanced imaging scans to guide the procedure. It focuses on patients with severe heart rhythm issues and heart damage. The goal is to make the treatment safer and more effective by precisely targeting problem areas in the heart.
Who is the study for?
This trial is for adults over 18 with severe heart issues, specifically those with a very low ejection fraction (EF≤25%) or slightly higher EF (EF≤35%) but with advanced heart failure symptoms or hospitalization history. Participants must have had recent imaging tests showing moderate to severe dysfunction in the right side of the heart.
What is being tested?
The STABLE-VT trial is testing a new method for treating irregular heartbeats called ventricular tachycardia (VT). This method uses detailed images from CT scans or cardiac MRIs to guide the procedure that targets electrical faults in the heart.
What are the potential side effects?
While specific side effects are not listed, VT ablation procedures can generally include risks such as bleeding at the catheter site, damage to blood vessels or heart tissue, and potential worsening of arrhythmias.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major adverse cardiovascular events (MACE)
Number of Participants Requiring Inotropic support use
Number of Participants Requiring Mechanical circulatory support use
+3 moreSecondary study objectives
Antiarrhythmic Drugs requirement
Cumulative procedural inotropic support use
Experimental procedural duration
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Imaging-aided VT ablationExperimental Treatment1 Intervention
For subjects assigned to the imaging-aided VT ablation arm, CT and/or c-MRI derived myocardial scar will be merged with 3D electroanatomical mapping (EAM) prior to the ablation to allow for readily localization and characterization of VT substrates and potential re-entry circuits to be ablated. This integrated mapping of VT substrates sites to be ablated will be given to the electrophysiologist prior to the ablation.
Group II: Standard of Care ArmActive Control1 Intervention
Standard of care procedural steps per respective institution and attending physician's clinical practice.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for cardiovascular disease (CVD) include lifestyle modifications, pharmacotherapy, and interventional procedures. Lifestyle changes such as diet and exercise are foundational, aiming to reduce risk factors like hypertension and hyperlipidemia.
Pharmacotherapy often involves antiplatelet agents, statins, and antihypertensives to manage blood pressure, cholesterol levels, and prevent clot formation. Interventional procedures, such as percutaneous coronary interventions (PCI) and ablation therapies, directly address structural heart issues.
The Modified VT Ablation with c-MRI/CT Integration specifically targets myocardial scar tissue to prevent arrhythmias by using advanced imaging techniques for precise ablation. This precision is crucial for improving outcomes and reducing complications in CVD patients.
[Percutaneous repair of mitral regurgitation: a new tool in the armamentarium for advanced heart failure?].Central venous disease in hemodialysis patients: an update.
[Percutaneous repair of mitral regurgitation: a new tool in the armamentarium for advanced heart failure?].Central venous disease in hemodialysis patients: an update.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,726,692 Total Patients Enrolled