NCT06371729 DEEP Substrate Mapping Versus Activation Mapping for VT
| NCT ID | NCT06371729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Ospedale San Raffaele |
| Condition | Ventricular Tachycardia |
| Study Type | INTERVENTIONAL |
| Enrollment | 222 participants |
| Start Date | 2024-06-13 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 222 participants in total. It began in 2024-06-13 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Substrate-based DEEP mapping and activation mapping are two of the main techniques used for guiding ventricular tachycardia (VT) ablation. There is no data comparing directly the extent of applicability, procedural results, and the long-term outcomes between the two mapping strategies.This randomized clinical trial aims to test whether activation mapping is superior to DEEP mapping to reduce ventricular tachycardia recurrence. The primary endpoint of the study is to compare recurrence-free survival rate of ventricular tachycardia at 12 months and procedural feasibility of substrate-based DEEP mapping versus activation mapping for VT ablation.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06371729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Tachycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06371729 currently recruiting?
Yes, NCT06371729 is actively recruiting participants. Contact the research team at radinovic.andrea@hsr.it for enrollment information.
Where is the NCT06371729 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06371729 clinical trial?
NCT06371729 is sponsored by IRCCS Ospedale San Raffaele. The trial plans to enroll 222 participants.