Ventricular Tachycardia (VT)NCT06669299
Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies
A study testing Re-Do ventricular tachycardia ablation and Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine) in people with Ventricular Tachycardia (VT), run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial summary
The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT)
- What is being tested?
- Re-Do ventricular tachycardia ablation and Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital, Arrhythmology and Electrophysiology unit
Milan, Italy, 20132
Paolo Della Bella, MD, +39 0226436247, dellabella.paolo@hsr.it
Andrea Radinovic, MD, radinovic.andrea@hsr.it
About this study
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
The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. The primary objective is to establish whether a new VT ablation based on NIPS inducibility will reduce the risk of VT recurrence compared to antiarrhythmic drug therapy.
Read the detailed description
The value of non-invasive programmed ventricular stimulation (NIPS) in the setting of ablation of ventricular tachycardia (VT) in patients with structural heart disease has been the object of studies in the last decade.
The technique is based on the feature, uniformly available in the Implantable Cardioverter-Defibrillator (ICD), to perform a complete programmed stimulation study from the apex of the right ventricle to assess the inducibility of ventricular tachycardia, similar to what is routinely performed during an invasive electrophysiology procedure. Data from our group indicate that 26% of patients who were non-inducible (apparent success) at the end of the ablation session become re-inducible to ventricular tachycardia at "late" NIPS (day 6). This finding, possibly related to partial recovery of conduction within the treated area, had prognostic significance, as it was associated with a 6-fold increased risk of VT recurrence at follow-up.
Recently Muser et al. reported similar findings (45/216 -21% of patients had clinical VT induced) with "late" NIPS performed on day 3. However, within this group of patients, the VT recurrence rate was significantly lower in those who had undergone, based on this finding, a re-do VT ablation as compared to those treated conservatively (rec in 1/11 of the Re-do ablation group, 9% vs. 24/34 in the conservative treatment group, 71%, p<0.01).
These data, however, originated from a retrospective observational analysis, where the indication of ablation was based on empirical physician preference.
No prospective randomized data compare the conservative attitude versus performing a new ablation in subjects who did not obtain a stable result after the first one. Therefore, this randomized multicenter clinical study aims to evaluate whether the repetition (Re-Do) of VT ablation process is superior to conservative medical therapy for reducing VT recurrences on post-procedural NIPS.
- Conditions
- Ventricular Tachycardia (VT)
- Being tested
- Re-Do ventricular tachycardia ablation, Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)
- Keywords
- Ventricular Tachycardia, VT, Non-Invasive Programmed Stimulation, NIPS, ICD, Implantable Cardioverter Defibrillator
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-Do ventricular tachycardia ablationProcedure or surgery
- Programmed ventricular stimulation (PVS); 2. Mapping during Sinus Rhythm (SR) or right ventricular pacing in pacing dependent patients; 3. Late Potentials identification; 4. VT(s) induction with diastolic pathway mapping when possible; 5. Catheter Ablation in SR or, at the operator's discretion, in VT if tolerated by the patient; 6. If VT is not inducible or the diastolic pathway is not mappable, a substrate ablation approach will be performed. 7. PVS is repeatedly attempting to reinduce VT after completing; 8. Endpoint: non-inducibility of any VT.
Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)Drug
The patients with a positive NIPS already on antiarrhythmic drugs (AAD) before the index procedure will re-start the original antiarrhythmic therapy. Patients who were not on AAD will start a new drug at the operator's discretion (amiodarone, sotalol, or mexiletine) according to clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AAD therapy Receives: Drug: Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine) |
| Group 2 | Experimental | Re-Do ablation procedure Receives: Procedure: Re-Do ventricular tachycardia ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VT recurrence free survival rate
Compare the efficacy on the reduction of VT recurrence of a NIPS-based Re-Do VT ablation versus antiarrhythmic drug therapy
Measured: 12 months after the procedure
Secondary outcomes (4)
Number of ICD shocks
Measured: Procedural, periprocedural, 6 and 12 months after procedure
Proportion of patients with VT storm
Measured: Procedural, periprocedural, 6 and 12 months after procedure
Rate of subsequent hospitalization for VT recurrence/HF.
Measured: Procedural, periprocedural, 6 and 12 months after procedure
Cardiac mortality
Measured: Procedural, periprocedural, 6 and 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start12 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paolo Della Bella, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669299
- Sponsor's protocol ID
- NIPS
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Della Bella P, Peretto G, Paglino G, Bisceglia C, Radinovic A, Sala S, Baratto F, Limite LR, Cireddu M, Marzi A, D'Angelo G, Vergara P, Gulletta S, Mazzone P, Frontera A. Bipolar radiofrequency ablation for ventricular tachycardias originating from the interventricular septum: Safety and efficacy in a pilot cohort study. Heart Rhythm. 2020 Dec;17(12):2111-2118. doi: 10.1016/j.hrthm.2020.06.025. Epub 2020 Jun 26.
PubMed 32599177Irie T, Yu R, Bradfield JS, Vaseghi M, Buch EF, Ajijola O, Macias C, Fujimura O, Mandapati R, Boyle NG, Shivkumar K, Tung R. Relationship between sinus rhythm late activation zones and critical sites for scar-related ventricular tachycardia: systematic analysis of isochronal late activation mapping. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):390-9. doi: 10.1161/CIRCEP.114.002637. Epub 2015 Mar 4.
PubMed 25740836Muser D, Hayashi T, Castro SA, Supple GE, Schaller RD, Santangeli P, Arkles J, Kumareswaran R, Nazarian S, Deo R, Lin D, Dixit S, Epstein AE, Callans DJ, Marchlinski FE, Frankel DS. Noninvasive Programmed Ventricular Stimulation-Guided Management Following Ventricular Tachycardia Ablation. JACC Clin Electrophysiol. 2019 Jun;5(6):719-727. doi: 10.1016/j.jacep.2019.03.007. Epub 2019 May 1.
PubMed 31221360Oloriz T, Baratto F, Trevisi N, Barbaro M, Bisceglia C, D'Angelo G, Yamase M, Paglino G, Radinovic A, Della Bella P. Defining the Outcome of Ventricular Tachycardia Ablation: Timing and Value of Programmed Ventricular Stimulation. Circ Arrhythm Electrophysiol. 2018 Mar;11(3):e005602. doi: 10.1161/CIRCEP.117.005602.
PubMed 29545359
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06669299
- Acronym / sponsor ID
- NIPS
- Conditions
- Ventricular Tachycardia (VT)
- Keywords
- Ventricular Tachycardia, VT, Non-Invasive Programmed Stimulation, NIPS, ICD, Implantable Cardioverter Defibrillator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. The primary objective is to establish whether a new VT ablation based on NIPS inducibility will reduce the risk of VT recurrence compared to antiarrhythmic drug therapy.
Detailed description
The value of non-invasive programmed ventricular stimulation (NIPS) in the setting of ablation of ventricular tachycardia (VT) in patients with structural heart disease has been the object of studies in the last decade.
The technique is based on the feature, uniformly available in the Implantable Cardioverter-Defibrillator (ICD), to perform a complete programmed stimulation study from the apex of the right ventricle to assess the inducibility of ventricular tachycardia, similar to what is routinely performed during an invasive electrophysiology procedure. Data from our group indicate that 26% of patients who were non-inducible (apparent success) at the end of the ablation session become re-inducible to ventricular tachycardia at "late" NIPS (day 6). This finding, possibly related to partial recovery of conduction within the treated area, had prognostic significance, as it was associated with a 6-fold increased risk of VT recurrence at follow-up.
Recently Muser et al. reported similar findings (45/216 -21% of patients had clinical VT induced) with "late" NIPS performed on day 3. However, within this group of patients, the VT recurrence rate was significantly lower in those who had undergone, based on this finding, a re-do VT ablation as compared to those treated conservatively (rec in 1/11 of the Re-do ablation group, 9% vs. 24/34 in the conservative treatment group, 71%, p<0.01).
These data, however, originated from a retrospective observational analysis, where the indication of ablation was based on empirical physician preference.
No prospective randomized data compare the conservative attitude versus performing a new ablation in subjects who did not obtain a stable result after the first one. Therefore, this randomized multicenter clinical study aims to evaluate whether the repetition (Re-Do) of VT ablation process is superior to conservative medical therapy for reducing VT recurrences on post-procedural NIPS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)AAD therapy |
| Group 2 | Experimental | Procedure: Re-Do ventricular tachycardia ablationRe-Do ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-Do ventricular tachycardia ablation1. Programmed ventricular stimulation (PVS); 2. Mapping during Sinus Rhythm (SR) or right ventricular pacing in pacing dependent patients; 3. Late Potentials identification; 4. VT(s) induction with diastolic pathway mapping when possible; 5. Catheter Ablation in SR or, at the operator's discretion, in VT if tolerated by the patient; 6. If VT is not inducible or the diastolic pathway is not mappable, a substrate ablation approach will be performed. 7. PVS is repeatedly attempting to reinduce VT after completing; 8. Endpoint: non-inducibility of any VT. | Procedure or surgery | Group 2 |
| Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine)The patients with a positive NIPS already on antiarrhythmic drugs (AAD) before the index procedure will re-start the original antiarrhythmic therapy. Patients who were not on AAD will start a new drug at the operator's discretion (amiodarone, sotalol, or mexiletine) according to clinical practice. | Drug | Group 1 |
Primary outcome
VT recurrence free survival rate
Time frame: 12 months after the procedure
Compare the efficacy on the reduction of VT recurrence of a NIPS-based Re-Do VT ablation versus antiarrhythmic drug therapy
4 secondary outcomes
Number of ICD shocks
Time frame: Procedural, periprocedural, 6 and 12 months after procedure
Proportion of patients with VT storm
Time frame: Procedural, periprocedural, 6 and 12 months after procedure
Rate of subsequent hospitalization for VT recurrence/HF.
Time frame: Procedural, periprocedural, 6 and 12 months after procedure
Cardiac mortality
Time frame: Procedural, periprocedural, 6 and 12 months after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 32599177Della Bella P, Peretto G, Paglino G, Bisceglia C, Radinovic A, Sala S, Baratto F, Limite LR, Cireddu M, Marzi A, D'Angelo G, Vergara P, Gulletta S, Mazzone P, Frontera A. Bipolar radiofrequency ablation for ventricular tachycardias originating from the interventricular septum: Safety and efficacy in a pilot cohort study. Heart Rhythm. 2020 Dec;17(12):2111-2118. doi: 10.1016/j.hrthm.2020.06.025. Epub 2020 Jun 26.
- Results publication: PubMed 25740836Irie T, Yu R, Bradfield JS, Vaseghi M, Buch EF, Ajijola O, Macias C, Fujimura O, Mandapati R, Boyle NG, Shivkumar K, Tung R. Relationship between sinus rhythm late activation zones and critical sites for scar-related ventricular tachycardia: systematic analysis of isochronal late activation mapping. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):390-9. doi: 10.1161/CIRCEP.114.002637. Epub 2015 Mar 4.
- Results publication: PubMed 31221360Muser D, Hayashi T, Castro SA, Supple GE, Schaller RD, Santangeli P, Arkles J, Kumareswaran R, Nazarian S, Deo R, Lin D, Dixit S, Epstein AE, Callans DJ, Marchlinski FE, Frankel DS. Noninvasive Programmed Ventricular Stimulation-Guided Management Following Ventricular Tachycardia Ablation. JACC Clin Electrophysiol. 2019 Jun;5(6):719-727. doi: 10.1016/j.jacep.2019.03.007. Epub 2019 May 1.
- Results publication: PubMed 29545359Oloriz T, Baratto F, Trevisi N, Barbaro M, Bisceglia C, D'Angelo G, Yamase M, Paglino G, Radinovic A, Della Bella P. Defining the Outcome of Ventricular Tachycardia Ablation: Timing and Value of Programmed Ventricular Stimulation. Circ Arrhythm Electrophysiol. 2018 Mar;11(3):e005602. doi: 10.1161/CIRCEP.117.005602.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Do ventricular tachycardia ablation and Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine) in people with Ventricular Tachycardia (VT), run by IRCCS Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Radinovic, MD (+39 0226436316, radinovic.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VT recurrence free survival rate (time frame: 12 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06669299, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.