Using your ICD's non-invasive stimulation to decide on a repeat VT ablation or medication
Official title: 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
Run by IRCCS Ospedale San Raffaele · NCT06669299 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 51 (estimated) |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan, Italy) |
| Status | Recruiting |
| Started | June 12, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT06669299 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Risk of malignant arrhythmias after acute coronary syndrome
This study tracks how often dangerous heart rhythms occur in adults admitted for ACS and looks for patterns that might predict them.
-
Targeted ablation to block scar channels that cause ventricular tachycardia
This study tests whether targeted radiofrequency ablation of scar-channel exits can prevent ventricular tachycardia in patients with scarred hearts.
-
Predict Arrhythmia Risk with Intelligent Software
Researchers are testing AI-powered predictions to see if clinicians can spot patients at risk for dangerous heart rhythms using bedside ECG data.
-
Severe Complications During VT/PVC Ablation
This study looks at real-world cases to see what severe complications occur during VT or PVC ablations and how patients are managed afterward.
-
Non-invasive mapping to help treat ventricular tachycardia due to heart disease
This study tests a non-invasive mapping tool to guide VT ablation in adults with structural heart disease and prior heart attack.
-
Personalised VT substrate mapping with dynamic voltage mapping during ablation
A procedure study to see if using dynamic voltage mapping during VT ablation helps identify and treat scar-related electrical circuits in people with ventricular tachycardia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.