Impact of PREVENTIVE Substrate Ablation of Coronary Chronic Total Occlusion on Implantable cardioVerTer-Defibrillator Interventions

NCT03421834 | Completed DMC

• 1 other identifier: PREVENTIVE VT
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 5

Brief Summary

The aim of this study is to assess whether preventive substrate ablation of chronic total occlusion infarct-related artery (CTO-IRA) area in heart failure (HF) patients correlates with lower appropriate implantable cardiac defibrillator (ICD) therapies. In addition, the purpose of the study is to determine whether prophylactic substrate ablation at the time of primary ICD implantation in high-risk ischemic patients affects unplanned hospitalization, HF progression, and quality of life.

Conditions

Ventricular Tachycardia; Ischemic Cardiomyopathy

Keywords

Ventricular Tachycardia; Ischemic Cardiomyopathy; Primary prevention; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Time to first event comprising appropriate ICD therapy and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)

  Appropriate ICD therapy defined as shock or ATP therapy.

  From randomization until official study end or drop-out, patients will be followed and assessed at least 24 months.

Secondary Outcomes (8)

• Time to appropriate ICD therapy

  At least 24 months after enrolment

• Incidence of appropriate ICD therapy

  At least 24 months after enrolment

• Time to unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)

  At least 24 months after enrolment

• Time to unplanned cardiac hospital admission

  At least 24 months after enrolment

• Time to electrical storm

  At least 24 months after enrolment

Study Arms (2)

Prophylactic VT ablation prior to ICD implantation

EXPERIMENTAL

Procedure: Catheter ablation of ventricular tachycardia; Drug: Optimal medical treatment

ICD implantation and optimal medical treatment

ACTIVE COMPARATOR

ICD implantation and optimal medical care until at least 2 appropriate ICD shock occurs or an arrhythmic storm and catheter ablation thereafter.

Drug: Optimal medical treatment

Interventions

Catheter ablation of ventricular tachycardia PROCEDURE

Catheter ablation with a uniform mapping system, procedural endpoint, and definition of acute procedural success.

Prophylactic VT ablation prior to ICD implantation

Optimal medical treatment DRUG

Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. Antiarrhythmics will be avoided if possible in the ablation group.

ICD implantation and optimal medical treatment; Prophylactic VT ablation prior to ICD implantation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic cardiomyopathy with reduced ejection fraction (EF ≤ 40%) estimated by cardiac MRI or echocardiography within 30 days before enrollment
• Coronary Chronic Total Occlusion (CTO) associated with a previous MI confirmed by coronary angiography and late gadolinium enhancement MRI or myocardial perfusion imaging within 30 days before enrollment
• Implantable cardioverter-defibrillator (ICD) indication for primary prevention
• Patient has provided written informed consent

You may not qualify if:

• Age \< 18 years or \> 85 years
• Documented sustained ventricular tachycardia before enrollment
• Class IV New York Heart Association (NYHA) heart failure
• CTOs not associated with a prior infarction in their territory
• Acute myocardial infarction (MI) or acute coronary syndrome
• Subjects with active ischemia that are eligible for revascularization
• Documented history of MI less than 6 months before enrollment
• Patients requiring chronic renal dialysis
• Thrombocytopenia or coagulopathy
• Pre-existing implantable cardioverter-defibrillator (ICD)
• Pregnancy or breastfeeding women
• Acute illness or active systemic infection
• Life expectancy less than 12 months
• Unwillingness to participate or lack of availability for follow-up
• Valvular heart disease or mechanical heart valve precluding access to the left ventricle

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (5)

Klinički bolnički centar Sestre Milosrdnice

Zagreb, HR-10000, Croatia

Location

General Hospital Celje

Celje, 3000, Slovenia

Location

General Hospital Izola

Izola, 6310, Slovenia

Location

University Medical Centre Ljubljana - Cardiology department

Ljubljana, 1000, Slovenia

Location

University Medical Centre Ljubljana - Cardiovascular surgery department

Ljubljana, 1000, Slovenia

Location

Related Publications (9)

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098.

  PMID: 18768944 BACKGROUND

• Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457.

  PMID: 18160685 BACKGROUND

• Dinov B, Arya A, Bertagnolli L, Schirripa V, Schoene K, Sommer P, Bollmann A, Rolf S, Hindricks G. Early referral for ablation of scar-related ventricular tachycardia is associated with improved acute and long-term outcomes: results from the Heart Center of Leipzig ventricular tachycardia registry. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1144-51. doi: 10.1161/CIRCEP.114.001953. Epub 2014 Sep 27.

  PMID: 25262159 BACKGROUND

• Di Biase L, Burkhardt JD, Lakkireddy D, Carbucicchio C, Mohanty S, Mohanty P, Trivedi C, Santangeli P, Bai R, Forleo G, Horton R, Bailey S, Sanchez J, Al-Ahmad A, Hranitzky P, Gallinghouse GJ, Pelargonio G, Hongo RH, Beheiry S, Hao SC, Reddy M, Rossillo A, Themistoclakis S, Dello Russo A, Casella M, Tondo C, Natale A. Ablation of Stable VTs Versus Substrate Ablation in Ischemic Cardiomyopathy: The VISTA Randomized Multicenter Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2872-2882. doi: 10.1016/j.jacc.2015.10.026.

  PMID: 26718674 BACKGROUND

• Nombela-Franco L, Mitroi CD, Fernandez-Lozano I, Garcia-Touchard A, Toquero J, Castro-Urda V, Fernandez-Diaz JA, Perez-Pereira E, Beltran-Correas P, Segovia J, Werner GS, Javier G, Luis AP. Ventricular arrhythmias among implantable cardioverter-defibrillator recipients for primary prevention: impact of chronic total coronary occlusion (VACTO Primary Study). Circ Arrhythm Electrophysiol. 2012 Feb;5(1):147-54. doi: 10.1161/CIRCEP.111.968008. Epub 2011 Dec 28.

  PMID: 22205684 BACKGROUND

• Di Marco A, Anguera I, Teruel L, Dallaglio P, Gonzalez-Costello J, Leon V, Nunez E, Manito N, Gomez-Hospital JA, Sabate X, Cequier A. Chronic total occlusion of an infarct-related artery: a new predictor of ventricular arrhythmias in primary prevention implantable cardioverter defibrillator patients. Europace. 2017 Feb 1;19(2):267-274. doi: 10.1093/europace/euw009.

  PMID: 28175266 BACKGROUND

• Di Marco A, Anguera I, Teruel L, Muntane G, Campbell NG, Fox DJ, Brown B, Skene C, Davidson N, Leon V, Dallaglio P, Elzein H, Garcia-Romero E, Gomez-Hospital JA, Cequier A. Chronic total occlusion in an infarct-related coronary artery and the risk of appropriate ICD therapies. J Cardiovasc Electrophysiol. 2017 Oct;28(10):1169-1178. doi: 10.1111/jce.13290. Epub 2017 Aug 4.

  PMID: 28675508 BACKGROUND

• Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.

  PMID: 31698933 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Heart Failure

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matjaz Sinkovec, Prof.

  University Medical Centre Ljubljana (Slovenia)

  STUDY CHAIR

• Andrej Pernat, Prof.

  University Medical Centre Ljubljana (Slovenia)

  STUDY CHAIR

• David Zizek, Assist. Prof.

  University Medical Centre Ljubljana (Slovenia)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 5, 2018
• Study Start: February 6, 2018
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

SL (4); CR (1)