Comparing two methods of catheter ablation for ventricular tachycardia in heart disease patients
Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study
NA · Rennes University Hospital · NCT05888662
This study is testing if a new way of doing heart surgery can help people with heart disease and ventricular tachycardia feel better and have fewer heart rhythm problems compared to the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital (other) |
| Locations | 12 sites (Bordeaux and 11 other locations) |
| Trial ID | NCT05888662 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of endo-epicardial catheter ablation compared to traditional endocardial-only ablation for treating ventricular tachycardia in patients with ischemic cardiomyopathy. The study aims to address the high recurrence rates of ventricular tachycardia by targeting both the endocardial and epicardial layers of the heart. Patients will undergo their first radiofrequency ablation procedure, and the outcomes will be monitored to assess the success of the different approaches. The trial includes patients with implantable cardioverter-defibrillators and requires informed consent.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old experiencing their first episode of ventricular tachycardia due to ischemic heart disease.
Not a fit: Patients with a history of cardiac surgery that affects the epicardial approach or those who cannot temporarily discontinue anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced recurrence of ventricular tachycardia in patients with ischemic heart disease.
How similar studies have performed: While the endo-epicardial approach has been used in other contexts, this specific comparison in ischemic cardiomyopathy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients over 18 years of age 2. 1st radiofrequency ablation of VT complicating ischaemic heart disease 3. Patients with an ICD and remote monitoring 4. Having, for women of childbearing age, effective contraception until discharge from hospital 5. Have given their free and informed consent in writing 6. are affiliated to or have health insurance Exclusion Criteria: 1. History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardial adhesions) 2. Presence of a left intraventricular thrombus found during pre-procedure imaging 3. Anticoagulant therapy that cannot be temporarily discontinued 4. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy 5. History of pericarditis 6. Previous thoracic radiotherapy 7. Contraindication to general anaesthesia 8. Pregnant or breastfeeding woman 9. History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure) 10. Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent
Where this trial is running
Bordeaux and 11 other locations
- CHU de Bordeaux — Bordeaux, France (NOT_YET_RECRUITING)
- Centre Hospitalier Universitaire de Caen — Caen, France (NOT_YET_RECRUITING)
- Centre Hospitalier de Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
- Centre Hospitalier Régional Universitaire de Lille — Lille, France (NOT_YET_RECRUITING)
- Hospices Civils de Lyon — Lyon, France (NOT_YET_RECRUITING)
- CHU de Nantes — Nantes, France (RECRUITING)
- Hôpital Européen Georges Pompidou — Paris, France (RECRUITING)
- Hôpital Universitaire La Pitié-Salpêtrière - Paris — Paris, France (NOT_YET_RECRUITING)
- CHU de Rennes — Rennes, France (RECRUITING)
- Centre Hospitalier Universitaire de Saint-Étienne — Saint-Etienne, France (NOT_YET_RECRUITING)
- Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques — Toulouse, France (NOT_YET_RECRUITING)
- Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau — Tours, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Raphaël MARTINS, MD, PhD — Rennes University Hospital
- Study coordinator: Raphaël MARTINS, MD, PhD
- Email: raphael.martins@chu-rennes.fr
- Phone: 299282517
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.
Conditions: Ischemic Cardiomyopathy, Catheter Ablation of Ventricular Tachycardia, ischemic cardiomyopathy