Comparing radiofrequency ablation to implantable defibrillator for ventricular tachycardia in heart disease patients
International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction
This study is testing whether a procedure called radiofrequency ablation is better than an implantable defibrillator for helping heart disease patients with a specific type of fast heartbeat feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 268 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse, France) |
| Trial ID | NCT06294028 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of radiofrequency ablation versus implantable defibrillators in patients with ischemic heart disease who experience well-tolerated ventricular tachycardia and have minimally impaired left ventricular ejection fraction. The study will collect data on adverse events, assess quality of life using the EQ-5D-5L questionnaire, and perform a medical-economic evaluation. The goal is to determine if ablation can reduce mortality and recurrence rates in this specific patient population, which has not been extensively studied before.
Who should consider this trial
Good fit: Ideal candidates include patients with ischemic heart disease, a history of infarction, and sustained monomorphic ventricular tachycardia without syncope or cardiac arrest.
Not a fit: Patients with transient causes of ventricular tachycardia, recent myocardial infarction, or significant comorbidities that contraindicate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with ischemic heart disease and ventricular tachycardia.
How similar studies have performed: Previous studies have shown promising results for ablation in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ischemic heart disease with history of infarction - LVEF\> 35% (measured by MRI) * sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest - * having signed informed consent * affiliated to a social security system Exclusion Criteria: * transient regressive cause of ventricular tachycardia * recent myocardial infarction (\<2 months) * ventricular tachycardia by reentry from branch to branch * serious conduction disturbances (with indication of stimulation) * contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy \<1 year, relevant comorbidities) * pregnancy * age \<18 years * Patient under legal protection, guardianship or curatorship
Where this trial is running
Toulouse, France
- Rangueil Hospital — Toulouse, France, France (Recruiting)
Study contacts
- Principal investigator: Philippe MAURY, MD — University Hospital, Toulouse
- Study coordinator: Philippe MAURY, MD
- Email: maury.p@chu-toulouse.fr
- Phone: 5 61 34 10 18
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.