Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study
Comparing two heart rhythm mapping methods for ventricular tachycardia
Plain English Summary
DEEP Substrate Mapping Versus Activation Mapping for VT is a Not Applicable clinical trial sponsored by IRCCS Ospedale San Raffaele studying Ventricular Tachycardia. This study compares two methods, DEEP mapping and activation mapping, used to guide procedures for ventricular tachycardia (VT), a dangerous heart rhythm. It is for patients with an implanted heart device who need a procedure to treat VT caused by conditions like heart attack or inflammation. Participants will be randomly assigned to one of the two mapping methods, and their outcomes will be tracked for 12 months. Standard treatment for VT involves medication or procedures to correct the heart rhythm, but this study aims to find the best way to guide these procedures. The trial aims to enroll 222 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with an implanted defibrillator (ICD) are eligible. Individuals needing a procedure to treat VT caused by previous heart attack, myocarditis, or genetic heart conditions can join. Participants must be 18 years or older and able to provide informed consent. People with blood clotting issues, artificial heart valves, recent heart attack, or a life expectancy less than one year cannot participate. This trial is studying Ventricular Tachycardia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how often ventricular tachycardia returns within 12 months after the procedure, and how successfully the mapping methods can be used to guide the treatment. The specific primary outcome measures are: VT recurrence free survival rate (after 12 months from the procedure); Procedural feasibility (During the index procedure). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it will help determine the best method for guiding procedures to treat ventricular tachycardia, potentially reducing the risk of the dangerous rhythm returning. This research targets Ventricular Tachycardia, where improved treatment options are needed.
Investor Insight
This trial addresses a critical need in managing ventricular tachycardia, a condition affecting a significant patient population, with the goal of improving ablation success rates and potentially redu
Is This Trial Right for Me?
Ask your doctor about the potential risks and benefits of each mapping method and what to expect during the procedure. Participation involves undergoing one of the two mapping procedures and attending follow-up appointments for 12 months. You will need to take medications as prescribed and report any new symptoms or side effects to your healthcare team. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 222 participants
Interventions
- PROCEDURE: DEEP mapping — 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 dia
- PROCEDURE: Activation Mapping — 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
Primary Outcomes
- VT recurrence free survival rate (after 12 months from the procedure)
- Procedural feasibility (During the index procedure)
Secondary Outcomes
- Procedural data. (During the index procedure)
- Hemodynamic VT tolerance (During the index procedure)
- Clinical follow up data. (after 12 months from the procedure)
Full 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.
Trial Locations
- San Raffaele Hospital, Milan, Lombardy, Italy
Frequently Asked Questions
What is clinical trial NCT06371729?
NCT06371729 is a Not Applicable INTERVENTIONAL study titled "DEEP Substrate Mapping Versus Activation Mapping for VT." It is currently recruiting and is sponsored by IRCCS Ospedale San Raffaele. The trial targets enrollment of 222 participants.
What conditions does NCT06371729 study?
This trial investigates treatments for Ventricular Tachycardia. The primary condition under study is Ventricular Tachycardia.
What treatments are being tested in NCT06371729?
The interventions being studied include: DEEP mapping (PROCEDURE), Activation Mapping (PROCEDURE). 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 dia
What does Not Applicable mean for NCT06371729?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06371729?
This trial is currently "Recruiting." It started on 2024-06-13. The estimated completion date is 2027-06.
Who is sponsoring NCT06371729?
NCT06371729 is sponsored by IRCCS Ospedale San Raffaele. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06371729?
The trial aims to enroll 222 participants. The trial is currently recruiting and accepting new participants.
How is NCT06371729 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06371729?
The primary outcome measures are: VT recurrence free survival rate (after 12 months from the procedure); Procedural feasibility (During the index procedure). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06371729 being conducted?
This trial is being conducted at 1 site, including Milan, Lombardy (Italy).
Where can I find official information about NCT06371729?
The official record for NCT06371729 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06371729. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06371729 testing in simple terms?
This study compares two methods, DEEP mapping and activation mapping, used to guide procedures for ventricular tachycardia (VT), a dangerous heart rhythm. It is for patients with an implanted heart device who need a procedure to treat VT caused by conditions like heart attack or inflammation.
Why is this trial significant?
This trial is important because it will help determine the best method for guiding procedures to treat ventricular tachycardia, potentially reducing the risk of the dangerous rhythm returning.
What are the potential risks of participating in NCT06371729?
Potential risks include bleeding, infection, or damage to the heart during the procedure. Common side effects may include bruising at the insertion site, temporary discomfort, or fatigue. There is a risk that the procedure may not be successful in preventing the return of ventricular tachycardia. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06371729?
Ask your doctor about the potential risks and benefits of each mapping method and what to expect during the procedure. Participation involves undergoing one of the two mapping procedures and attending follow-up appointments for 12 months. You will need to take medications as prescribed and report any new symptoms or side effects to your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06371729 signal from an investment perspective?
This trial addresses a critical need in managing ventricular tachycardia, a condition affecting a significant patient population, with the goal of improving ablation success rates and potentially redu This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to one of the two mapping methods, and their outcomes will be tracked for 12 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Ventricular Tachycardia Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.