WithdrawnNot Applicable

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

Stopped: Potential protocol modifications are pending, and enrollment has been challenging.

United States0Started 2023-10-01

Plain-language summary

The STABLE-VT trial aims to determine the safety profile and clinical efficacy of a modified approach to ventricular tachycardia (VT) ablation that integrates myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients (\>18 years old) diagnosed with severely reduced ejection fraction defined as EF≤25% or EF≤ 35% with concurrent NYHA class III/IV heart failure symptoms and/or at least one previous heart failure hospitalization in the previous 6 months) who are referred for VT ablation. * Patients with moderate to severe RV dysfunction diagnosed on most recent imaging (echo/c-MRI). * Patients with must have undergone the imaging (c-MRI and/or CT) required for the investigational VT approach to qualify for participation. Exclusion Criteria: * Patients in whom Impella/ECMO or anesthesia is indicated prior to or at presentation to the EP lab. * Patients for whom an informed consent cannot be obtained. * Patients who are found to be pregnant using detection of human chorionic gonadotropin (hcg) as done as part of standard of care, will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major adverse cardiovascular events (MACE)

Timeframe: during hospital stay following ablation procedure, up to 1 week

Number of Participants Requiring Mechanical circulatory support use

Timeframe: During the procedure, 24-48 hours after the ablation procedure

Number of Participants Requiring Inotropic support use

Timeframe: During the procedure, 24-48 hours after the ablation procedure

Number of Participants With Clinically Significant Pericardial Effusion

Timeframe: During the procedure, up to 24 hours after the ablation procedure

Number of Participants With Acute kidney injury

Timeframe: During procedure, up to 24-48 hours after the ablation procedure

Number of Participants Requiring intubation

Timeframe: During procedure, 24 hours after the ablation procedure

Trial details

NCT IDNCT05828667

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Cardiovascular Diseases trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Major adverse cardiovascular events (MACE)

Timeframe: during hospital stay following ablation procedure, up to 1 week

Number of Participants Requiring Mechanical circulatory support use

Timeframe: During the procedure, 24-48 hours after the ablation procedure

Number of Participants Requiring Inotropic support use

Timeframe: During the procedure, 24-48 hours after the ablation procedure

Number of Participants With Clinically Significant Pericardial Effusion

Timeframe: During the procedure, up to 24 hours after the ablation procedure

Number of Participants With Acute kidney injury

Timeframe: During procedure, up to 24-48 hours after the ablation procedure

Number of Participants Requiring intubation

Timeframe: During procedure, 24 hours after the ablation procedure