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

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ClinicalTrials.gov Identifier: NCT04675073
Recruitment Status : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio Berruezo, MD, PhD, Centro Medico Teknon

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Ventricular Arrythmia Sudden Cardiac Death Sudden Cardiac Death Due to Cardiac Arrhythmia Ischemic Heart Disease Myocardial Infarction Magnetic Resonance Imaging Procedure: Ventricular tachycardia substrate-based radiofrequency ablation Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventive VT Substrate Ablation in Patients With Chronic Post-MI Scar Showing Arrhythmogenic Characteristics
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: 2 years ]
    Procedure time

  2. Radiofrequency time [ Time Frame: 2 years ]
    Radiofrequency time

  3. Rate of achievement of complete substrate ablation [ Time Frame: 2 years ]
    Rate of achievement of complete substrate ablation

  4. VT inducibility rate [ Time Frame: 2 years ]
    Final VT inducibility rate

  5. Rate of complications [ Time Frame: 2 years ]
    Rate of complications

  6. Rate of need for anti-arrhythmic drugs [ Time Frame: 2 years ]
    Rate of need for anti-arrhythmic drugs in both arms of the study


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675073


Contacts
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Contact: Antonio Berruezo, MD, PhD (+34) 93 290 62 51 antonio.berruezo@quironsalud.es

Sponsors and Collaborators
Centro Medico Teknon
Investigators
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Principal Investigator: Antonio Berruezo, MD, PhD Centro Médico Teknon
More Information
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Publications:

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Responsible Party: Antonio Berruezo, MD, PhD, Head of Arrhythmia Section, Centro Medico Teknon
ClinicalTrials.gov Identifier: NCT04675073    
Other Study ID Numbers: PREVENT-VT
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Berruezo, MD, PhD, Centro Medico Teknon:
ventricular tachycardia
ventricular arrhythmia
sudden cardiac death
 ischemic heart disease
cardiac magnetic resonance
border zone channels
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Diseases
Arrhythmias, Cardiac
Tachycardia
Myocardial Ischemia
Coronary Artery Disease
Tachycardia, Ventricular
Death, Sudden, Cardiac
Ischemia
Death
Pathologic Processes
 Infarction
Necrosis
Cardiovascular Diseases
Vascular Diseases
Cardiac Conduction System Disease
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Heart Arrest
Death, Sudden