Using your ICD's non-invasive stimulation to decide on a repeat VT ablation or medication
The Value of Late Non-Invasive Programmed Stimulation (NIPS) in the Setting of Ventricular Tachycardia (VT) Ablation to Guide the Subsequent VT Therapeutic Strategies: a Prospective Randomized Multicenter Study
This will test whether using non-invasive programmed stimulation via your ICD to guide a repeat VT ablation reduces recurrence of ventricular tachycardia compared with taking antiarrhythmic drugs in people who become inducible a few days after an apparently successful ablation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06669299 on ClinicalTrials.gov |
What this trial studies
Patients who have had a successful catheter ablation for ventricular tachycardia will undergo non-invasive programmed stimulation (NIPS) through their implanted ICD 3–7 days after the procedure to check for re-inducibility of monomorphic VT. Those found to be inducible on NIPS are allocated to either a repeat (re-do) VT ablation or to antiarrhythmic drug therapy (amiodarone, sotalol, or mexiletine). The trial will compare rates of VT recurrence during follow-up between the two groups to determine whether an NIPS-guided re-ablation strategy lowers recurrence. The study is conducted at the Arrhythmology and Electrophysiology unit of IRCCS Ospedale San Raffaele in Milan and enrolls adults with structural heart disease and an implanted ICD.
Who should consider this trial
Good fit: Adults with an implanted ICD who had a successful index VT ablation (non-inducible at the end of the procedure) for ischemic or non-ischemic structural heart disease and who become inducible on NIPS 3–7 days later are the intended participants.
Not a fit: Patients who are not re-inducible on NIPS, those with VT from reversible causes, people with contraindications to anticoagulation or re-ablation, or those with limited life expectancy are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, an NIPS-guided approach could lower VT recurrence and reduce ICD therapies and hospital visits by identifying patients who benefit from an early re-do ablation.
How similar studies have performed: Retrospective observational series have shown that late NIPS re-inducibility predicts higher recurrence and that patients undergoing re-do ablation had lower recurrence than conservatively treated patients, but randomized evidence is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with an implanted ICD (all brands) * Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the "index procedure", supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies: previous MI, myocarditis, ARVD, IDCM. * Induction of monomorphic VT at NIPS 3-7days after a successful index procedure * Age 18 years or more * Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol. Exclusion Criteria: * Inducible VT after index procedure * Contraindication to anticoagulants * Presence of thrombi * Presence of Mitral and Aortic prosthetic valve * Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass * Pregnant or nursing * Ventricular Tachycardia caused by reversible pathology * \< 1 Year life expectancy according to the investigator
Where this trial is running
Milan, Italy
- San Raffaele Hospital, Arrhythmology and Electrophysiology unit — Milan, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Radinovic, MD
- Email: radinovic.andrea@hsr.it
- Phone: +39 0226436316
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.