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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

STABLE-VT Trial Summary

This trial tests a new way to treat VT by combining MRI images of the heart and electrical mapping to target areas for treatment.

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.Check my eligibility

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.See study design

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.

STABLE-VT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major adverse cardiovascular events (MACE)

Number of Participants Requiring Inotropic support use

Number of Participants Requiring Mechanical circulatory support use

+3 more

Secondary outcome measures

Antiarrhythmic Drugs requirement

Cumulative procedural inotropic support use

Experimental procedural duration

+6 more

STABLE-VT 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

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,267 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this scientific trial open to participants aged 75 or older?

"This clinical trial is recruiting individuals of legal age and below 90 years old."

Answered by AI

Am I eligible to participate in the research study?

"To qualify for this clinical trial, applicants should have a diagnosis of cardiovascular disease and be between 18 to 90 years old. Approximately 20 spots are available in the study."

Answered by AI

Are there any available openings for this research endeavor?

"The clinical trial is recruiting according to information posted on the clinicaltrials.gov website, which was most recently updated on October 27th 2023. Initial posting of the study took place on October 1st 2023."

Answered by AI

What is the current enrollment for this research project?

"Affirmative. According to clinicaltrials.gov, this study is still looking for candidates and was initially posted on October 1st of 2023. The latest update occurred on October 27th and the trial aims to recruit 20 patients from a single medical centre."

Answered by AI

What are the main aims of this clinical experiment?

"This clinical trial primarily aims to measure the number of participants requiring intubation during and up to 24-48 hours after the ablation procedure. Secondary outcomes include an assessment of left ventricular ejection fraction (LVEF) change at 6 months, freedom from VT noninvasively post treatment, and time to recurrent ventricular tachycardia (VT)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT.

2023. "The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05828667.