Ventricular TachycardiaNCT06371729
DEEP Substrate Mapping Versus Activation Mapping for VT
A study testing DEEP mapping and Activation Mapping in people with Ventricular Tachycardia, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- DEEP mapping and Activation Mapping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2024to Jun 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 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.
Who cannot join
- 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.
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
Milan, Lombardy, 20132
Paolo Della Bella, MD
Andrea Radinovic, MD
About this study
Official title: Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study
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.
- Conditions
- Ventricular Tachycardia
- Being tested
- DEEP mapping, Activation Mapping
- Keywords
- DEEP substrate mapping, Activation mapping
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEEP mappingProcedure or surgery
The Substrate-based DEEP Mapping aims to identify the arrhythmogenic substrate of VT in sinus rhythm (SR). A standardized VT mapping and ablation procedure in SR has been proven effective in reducing VT recurrences in a multicenter setting by targeting late potential (LP) abolition. Regions with LPs and LAVAs that displayed decremental behavior evoked during right ventricular (RV) pacing with extra stimuli (decrement-evoked potential; DEEP), colocalized with the regions of the initiation and diastolic pathway of the VT more accurately than those areas displaying non decremental LPs.
Device use for mapping and ablation procedure:
FlexAbility/Tactiflex/TactiCath Ablation Catheter Sensor Enabled (Abbott, MN), high-density grid mapping catheter (GMC; Advisor HD Grid Mapping Catheter Sensor Enabled, Abbott, MN)
Activation MappingProcedure or surgery
VT Activation Mapping can localize reentry circuits, and the diastolic pathway isthmus is the desirable target for ablation when possible because it can eliminate the elements required for reentry. In fact, activation mapping of the entire diastolic pathway is associated with higher freedom from VT recurrences compared to substrate modification
Device use for mapping and ablation procedure:
FlexAbility/Tactiflex/TactiCath Ablation Catheter Sensor Enabled (Abbott, MN), high-density grid mapping catheter (GMC; Advisor HD Grid Mapping Catheter Sensor Enabled, Abbott, MN)
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Substrate-based DEEP Mapping Receives: Procedure: DEEP mapping |
| group 2 | Experimental | VT Activation Mapping Receives: Procedure: Activation Mapping |
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 of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences
Measured: after 12 months from the procedure
Procedural feasibility
Percentage of patients in which the mapping strategy was achievable and reasons for failure.
Measured: During the index procedure
Secondary outcomes (3)
Procedural data.
Procedure duration (minutes)
Measured: During the index procedure
Hemodynamic VT tolerance
Hemodynamic decompensation during the procedure. (Arterial blood pressure <80 mmHg)
Measured: During the index procedure
Clinical follow up data.
- Number of ICD shocks at follow-up
- Rate of subsequent hospitalizations for VT recurrence/HF
- Cardiac mortality.
Measured: after 12 months from the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start13 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 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
- NCT06371729
- Sponsor's protocol ID
- DEEP-VT
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porta-Sanchez A, Jackson N, Lukac P, Kristiansen SB, Nielsen JM, Gizurarson S, Masse S, Labos C, Viswanathan K, King B, Ha ACT, Downar E, Nanthakumar K. Multicenter Study of Ischemic Ventricular Tachycardia Ablation With Decrement-Evoked Potential (DEEP) Mapping With Extra Stimulus. JACC Clin Electrophysiol. 2018 Mar;4(3):307-315. doi: 10.1016/j.jacep.2017.12.005. Epub 2018 Feb 3.
PubMed 30089555Jackson N, Gizurarson S, Viswanathan K, King B, Masse S, Kusha M, Porta-Sanchez A, Jacob JR, Khan F, Das M, Ha AC, Pashaei A, Vigmond E, Downar E, Nanthakumar K. Decrement Evoked Potential Mapping: Basis of a Mechanistic Strategy for Ventricular Tachycardia Ablation. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1433-42. doi: 10.1161/CIRCEP.115.003083. Epub 2015 Oct 19.
PubMed 26480929Hadjis A, Frontera A, Limite LR, Bisceglia C, Bognoni L, Foppoli L, Lipartiti F, Paglino G, Radinovic A, Tsitsinakis G, Calore F, Della Bella P. Complete Electroanatomic Imaging of the Diastolic Pathway Is Associated With Improved Freedom From Ventricular Tachycardia Recurrence. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008651. doi: 10.1161/CIRCEP.120.008651. Epub 2020 Jul 28.
PubMed 32755381
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
- Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT06371729
- Acronym / sponsor ID
- DEEP-VT
- Conditions
- Ventricular Tachycardia
- Keywords
- DEEP substrate mapping, Activation mapping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Procedure: DEEP mappingSubstrate-based DEEP Mapping |
| group 2 | Experimental | Procedure: Activation MappingVT Activation Mapping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| DEEP mappingThe Substrate-based DEEP Mapping aims to identify the arrhythmogenic substrate of VT in sinus rhythm (SR). A standardized VT mapping and ablation procedure in SR has been proven effective in reducing VT recurrences in a multicenter setting by targeting late potential (LP) abolition. Regions with LPs and LAVAs that displayed decremental behavior evoked during right ventricular (RV) pacing with extra stimuli (decrement-evoked potential; DEEP), colocalized with the regions of the initiation and diastolic pathway of the VT more accurately than those areas displaying non decremental LPs. Device use for mapping and ablation procedure: FlexAbility/Tactiflex/TactiCath Ablation Catheter Sensor Enabled (Abbott, MN), high-density grid mapping catheter (GMC; Advisor HD Grid Mapping Catheter Sensor Enabled, Abbott, MN) | Procedure or surgery | group 1 |
| Activation MappingVT Activation Mapping can localize reentry circuits, and the diastolic pathway isthmus is the desirable target for ablation when possible because it can eliminate the elements required for reentry. In fact, activation mapping of the entire diastolic pathway is associated with higher freedom from VT recurrences compared to substrate modification Device use for mapping and ablation procedure: FlexAbility/Tactiflex/TactiCath Ablation Catheter Sensor Enabled (Abbott, MN), high-density grid mapping catheter (GMC; Advisor HD Grid Mapping Catheter Sensor Enabled, Abbott, MN) | Procedure or surgery | group 2 |
Primary outcome
VT recurrence free survival rate
Time frame: after 12 months from the procedure
Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences
Procedural feasibility
Time frame: During the index procedure
Percentage of patients in which the mapping strategy was achievable and reasons for failure.
3 secondary outcomes
Procedural data.
Time frame: During the index procedure
Hemodynamic VT tolerance
Time frame: During the index procedure
Clinical follow up data.
Time frame: after 12 months from the 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.
- Background: PubMed 30089555Porta-Sanchez A, Jackson N, Lukac P, Kristiansen SB, Nielsen JM, Gizurarson S, Masse S, Labos C, Viswanathan K, King B, Ha ACT, Downar E, Nanthakumar K. Multicenter Study of Ischemic Ventricular Tachycardia Ablation With Decrement-Evoked Potential (DEEP) Mapping With Extra Stimulus. JACC Clin Electrophysiol. 2018 Mar;4(3):307-315. doi: 10.1016/j.jacep.2017.12.005. Epub 2018 Feb 3.
- Background: PubMed 26480929Jackson N, Gizurarson S, Viswanathan K, King B, Masse S, Kusha M, Porta-Sanchez A, Jacob JR, Khan F, Das M, Ha AC, Pashaei A, Vigmond E, Downar E, Nanthakumar K. Decrement Evoked Potential Mapping: Basis of a Mechanistic Strategy for Ventricular Tachycardia Ablation. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1433-42. doi: 10.1161/CIRCEP.115.003083. Epub 2015 Oct 19.
- Background: PubMed 32755381Hadjis A, Frontera A, Limite LR, Bisceglia C, Bognoni L, Foppoli L, Lipartiti F, Paglino G, Radinovic A, Tsitsinakis G, Calore F, Della Bella P. Complete Electroanatomic Imaging of the Diastolic Pathway Is Associated With Improved Freedom From Ventricular Tachycardia Recurrence. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008651. doi: 10.1161/CIRCEP.120.008651. Epub 2020 Jul 28.
- 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 DEEP mapping and Activation Mapping in people with Ventricular Tachycardia, 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 4 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 (+390226436316, 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: after 12 months from the procedure). The study lists 2 primary outcomes in all. 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 NCT06371729, which also lists 3 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.