Preventive VT Substrate Ablation in Ischemic Heart Disease (PREVENT-VT)

August 29, 2023 updated by: Antonio Berruezo, MD, PhD, Centro Medico Teknon

Preventive VT Substrate Ablation in Patients With Chronic Post-MI Scar Showing Arrhythmogenic Characteristics

The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (>5% of the LV mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from SMVT than in matched controls for age, sex, infarct location, and LVEF. However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of SCD. (7,8) In a recent, case-control study, the investigators identified the BZC mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain), with FDA 510(k) Clearance and CE Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of time (approx. 2 years).

On the other hand, catheter ablation has become an essential tool in the treatment of ventricular arrhythmias in patients with structural heart disease (SHD). VT ablation techniques have evolved towards substrate-based approaches that permit to abolish multiple VT circuits irrespective of their inducibility or hemodynamic tolerability, improving outcomes with respect to clinical VT ablation. Moreover, VT substrate ablation procedures performed during sinus rhythm and CMR-guided have proven to be safe, with very low procedure related complications.

The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08022
        • Recruiting
        • Centro Medico Teknon
        • Principal Investigator:
          • Antonio Berruezo, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Diego Penela, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18 years.
  • Chronic, stable ischemic heart disease, irrespectively of the LVEF.
  • Life expectancy of > 1 year with a good functional status.
  • Documented scar AND a BZC mass > 5.15 g as measured per LGE-CMR and automatic post-processing using the ADAS-3D LV (ADAS 3D Medical SL, Barcelona, Spain).
  • Signed informed consent.

Exclusion Criteria:

  • Age < 18 years.
  • Pregnancy.
  • Life expectancy of < 1 year, or bad functional status (NYHA IV functional class).
  • Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
  • Previously documented sustained ventricular arrhythmias.
  • Impossibility to perform a contrast-enhanced CMR study.
  • Calculated BZC mass in the scarred tissue < 5.15 g using the ADAS-3D LV software.
  • Concomitant investigation treatments.
  • Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABLATE arm
Ventricular tachycardia substrate ablation intending to: i) eliminate all the potential arrhythmogenic substrate, aiming for complete electrical isolation/elimination of all the electrograms with delayed components or showing hidden slow conduction properties, and ii) non-inducibility or ventricular tachycardias at the end of the procedure. Standard medical treatment will also be given for these patients.
Procedure: Ventricular tachycardia substrate-based radiofrequency ablation
The CARTO3 electroanatomic navigation system (Biosense Webster, Diamond Bar, CA, USA) will be used for ablation. An open irrigated 3.5-mm tip ablation catheter (ThermoCool SmartTouch, Biosense Webster, Diamond Bar, CA, USA) will be used for mapping and ablation. The first step of the procedure will be the acquisition of a fast-anatomical map (FAM) of the aorta. This FAM will be then used to integrate the multi-detector cardiac tomography (MDCT) reconstruction and cardiac magnetic resonance (CMR)-derived pixel-signal intensity (PSI) maps within the spatial reference coordinates of the CARTO3 system. RF will be delivered at the entrance of the border zone channels (BZCs) identified in the PSI maps (CMR-guided scar dechanneling technique). Programmed ventricular stimulation (PVS) will be always performed after substrate elimination to test for final inducibility.
No Intervention: NO-TREAT arm
Only standard medical treatment will be offered for these patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of sudden cardiac death or sustained ventricular tachycardia
Time Frame: 2 years
Composite outcome of sudden cardiac death or sustained ventricular tachycardia (either treated by an ICD or documented with continuous Holter monitoring) in patients undergoing preventive ventricular tachycardia (VT) substrate ablation vs. standard of care.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: 2 years
Procedure time
2 years
Radiofrequency time
Time Frame: 2 years
Radiofrequency time
2 years
Rate of achievement of complete substrate ablation
Time Frame: 2 years
Rate of achievement of complete substrate ablation
2 years
VT inducibility rate
Time Frame: 2 years
Final VT inducibility rate
2 years
Rate of complications
Time Frame: 2 years
Rate of complications
2 years
Rate of need for anti-arrhythmic drugs
Time Frame: 2 years
Rate of need for anti-arrhythmic drugs in both arms of the study
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Medico Teknon

Investigators

  • Principal Investigator: Antonio Berruezo, MD, PhD, Centro Medico Teknon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 29, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENT-VT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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