Comparing two mapping techniques for treating ventricular tachycardia
Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study
NA · IRCCS Ospedale San Raffaele · NCT06371729
This study is testing which of two mapping techniques helps people with ventricular tachycardia have fewer heart rhythm problems after treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele (other) |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06371729 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two mapping techniques, DEEP substrate mapping and activation mapping, for guiding ablation procedures in patients with ventricular tachycardia (VT). The study will randomly assign participants to receive one of the two mapping strategies to determine which is more effective in reducing the recurrence of VT. The primary endpoint is to evaluate the recurrence-free survival rate at 12 months post-procedure, along with assessing the feasibility of each mapping approach. By directly comparing these techniques, the trial seeks to provide insights into the best practices for VT ablation.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older with an implanted ICD and an indication for VT ablation due to specific heart conditions.
Not a fit: Patients with contraindications to anticoagulants, recent myocardial infarction, or reversible causes of ventricular tachycardia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing ablation for ventricular tachycardia by identifying the more effective mapping technique.
How similar studies have performed: While there is limited direct comparison data available, the approaches of DEEP and activation mapping have been utilized in other studies, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with an implanted ICD (all brands) * Patients with the indication for Ventricular Tachycardia Ablation (both first and redo procedures), supported by EnSite 3D mapping system, for the following disease aetiologies: previous MI, myocarditis, arrhythmogenic right/left ventricular dysplasia * Age: 18 years or more. * A participant is willing and able to give informed consent for participation in the trial and is available to respect the assessments described in the protocol and informed consent form. Exclusion Criteria: * Contraindication to anticoagulants. * Presence of thrombi. * Presence of Mitral and Aortic prosthetic valve. * Recent (less than 3 months) myocardial infarction, unstable angina, or Coronary Artery Bypass. * Ventricular Tachycardia caused by reversible pathology. * Life expectancy less than 1 year, according to the investigator. * Contraindications to the use of ablation/diagnostic catheters or to cardiac catheterization. * Female participant who is pregnant, lactating, or planning pregnancy during the course of the trial.
Where this trial is running
Milan, Lombardy
- San Raffaele Hospital — Milan, Lombardy, Italy (RECRUITING)
Study contacts
- Study coordinator: Andrea Radinovic, MD
- Email: radinovic.andrea@hsr.it
- Phone: +390226436316
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: Ventricular Tachycardia, DEEP substrate mapping, Activation mapping