CompletedNot Applicable

Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia

Spain180 participantsStarted 2010-07

Plain-language summary

To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.

Who can participate

Age range

18 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: * Ischemic cardiomyopathy, with ischemic myocardial scar * Sustained monomorphic ventricular tachycardia * Age \> 18 years * Prior ICD implantation Exclusion Criteria: * VT storm * NYHA functional class IV * Additional indication for antiarrhythmic drug therapy * Contraindication for both study drugs (amiodarone and sotalol). * Uncontrolled myocardial ischemia. * LV thrombus. * Non-ischemic VT substrate. * Contraindications for anticoagulation. * Prior substrate ablation in the previous 6 months * Cr \> 2.5 mg/dL * Mitral AND aortic mechanical valvular prosthesis

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

Occurrence of death from cardiovascular causes.

Timeframe: 2 years

Occurrence of appropriate shocks for VT/VF

Timeframe: 2 years

Occurrence of hospitalization for heart failure

Timeframe: 2 years

Occurrence of severe complication of the ablation procedure.

Timeframe: 2 years

Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects

Timeframe: 2 years

Trial details

NCT IDNCT03734562

SponsorHospital General Universitario Gregorio Marañon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09-29

View on ClinicalTrials.gov More Monomorphic Ventricular Tachycardia trials

Who can participate

Age range

18 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

Occurrence of death from cardiovascular causes.

Timeframe: 2 years

Occurrence of appropriate shocks for VT/VF

Timeframe: 2 years

Occurrence of hospitalization for heart failure

Timeframe: 2 years

Occurrence of severe complication of the ablation procedure.

Timeframe: 2 years

Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects

Timeframe: 2 years