Preventive treatment for heart rhythm issues in patients with ischemic heart disease
Preventive VT Substrate Ablation in Patients With Chronic Post-MI Scar Showing Arrhythmogenic Characteristics
This study is testing a new procedure to see if it can help prevent dangerous heart rhythms in people with chronic heart disease who have significant heart scarring.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Medico Teknon Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04675073 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of preventive ventricular tachycardia substrate ablation in patients with chronic ischemic heart disease who are at high risk for arrhythmias. Participants are selected based on imaging criteria that identify significant scarring in the heart, which is linked to the risk of sudden cardiac death. The study utilizes late gadolinium enhancement cardiac magnetic resonance imaging to assess the arrhythmogenic substrate and aims to reduce the occurrence of clinical ventricular tachycardia events through targeted radiofrequency ablation. The trial is designed as a Phase 3 interventional study to provide robust evidence for this approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic ischemic heart disease and documented scar tissue that meets specific imaging criteria.
Not a fit: Patients with other structural heart diseases, those under 18, or individuals with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of life-threatening heart rhythm disorders and sudden cardiac death in high-risk patients.
How similar studies have performed: While there is limited solid evidence from randomized trials, previous studies have indicated potential benefits of similar approaches in managing ventricular arrhythmias.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years. * Chronic, stable ischemic heart disease, irrespectively of the LVEF. * Life expectancy of \> 1 year with a good functional status. * Documented scar AND a BZC mass \> 5.15 g as measured per LGE-CMR and automatic post-processing using the ADAS-3D LV (ADAS 3D Medical SL, Barcelona, Spain). * Signed informed consent. Exclusion Criteria: * Age \< 18 years. * Pregnancy. * Life expectancy of \< 1 year, or bad functional status (NYHA IV functional class). * Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.) * Previously documented sustained ventricular arrhythmias. * Impossibility to perform a contrast-enhanced CMR study. * Calculated BZC mass in the scarred tissue \< 5.15 g using the ADAS-3D LV software. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Where this trial is running
Barcelona
- Centro Medico Teknon — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio Berruezo, MD, PhD — Centro Médico Teknon
- Study coordinator: Antonio Berruezo, MD, PhD
- Email: antonio.berruezo@quironsalud.es
- Phone: (+34) 93 290 62 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.