What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease, including VT ablation procedures, can have side effects such as bleeding, infection, damage to blood vessels, and arrhythmias. The use of imaging techniques like c-MRI and CT in these procedures generally has minimal side effects but may involve exposure to contrast agents, which can cause allergic reactions or kidney issues in some patients. Additionally, medications used in cardiovascular treatments, such as beta-blockers, ACE inhibitors, and anticoagulants, can cause side effects like dizziness, fatigue, and increased bleeding risk.

What prior FDA approvals exist?

The FDA has approved several treatments for cardiovascular disease that involve advanced imaging and ablation techniques. For instance, ibutilide and procainamide are antiarrhythmic agents approved for the rapid conversion of atrial fibrillation and atrial flutter, often used in conjunction with imaging techniques to enhance precision. Additionally, the use of cardiac magnetic resonance (c-MRI) and computed tomography (CT) in procedures like the STABLE-VT trial represents a significant advancement in targeting myocardial scar tissue during ventricular tachycardia (VT) ablation. These imaging modalities help improve the accuracy and efficacy of ablation therapies, leading to better patient outcomes.

What other types of research exist?

Promising novel alternatives to Modified VT Ablation with c-MRI/CT Integration for cardiovascular disease patients include: 1) Stereotactic Body Radiation Therapy (SBRT) for non-invasive ablation of arrhythmogenic foci, 2) Electroporation-based ablation techniques such as Pulsed Field Ablation (PFA) which selectively targets myocardial tissue with minimal collateral damage, and 3) Advanced imaging-guided catheter ablation techniques incorporating real-time MRI or high-resolution 3D electroanatomical mapping for improved precision in targeting arrhythmogenic substrates.

← Back to Search

Procedure

Imaging-Guided Ablation for Cardiovascular Disease (STABLE-VT Trial)

N/A

Recruiting

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Secondary study objectives

Antiarrhythmic Drugs requirement

Cumulative procedural inotropic support use

Experimental procedural duration

+6 more

Awards & 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.

Do I qualify?Apply below to find out

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.