Ventricular TachycardiaPREVENTIVE VTNCT03421834
Impact of PREVENTIVE Substrate Ablation of Coronary Chronic Total Occlusion on Implantable cardioVerTer-Defibrillator Interventions
A study testing Catheter ablation of ventricular tachycardia and Optimal medical treatment in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by University Medical Centre Ljubljana at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- What is being tested?
- Catheter ablation of ventricular tachycardia and Optimal medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 6 Feb 2018to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Slovenia4 sites
General Hospital Celje
Celje, 3000
General Hospital Izola
Izola, 6310
University Medical Centre Ljubljana - Cardiology department
Ljubljana, 1000
University Medical Centre Ljubljana - Cardiovascular surgery department
Ljubljana, 1000
About this study
Official title: Impact of PREVENTIVE Substrate Catheter Ablation on Implantable cardioVerter-defibrillaTor Interventions in Patients With Ischaemic Cardiomyopathy and Infarct-related Coronary Chronic Total Occlusion
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.
Read the detailed description
Implantable cardioverter-defibrillators (ICDs) improve survival among patients with ischemic heart failure (HF) who have not previously had a sustained ventricular arrhythmia. However, ICD shocks that terminate ventricular tachycardia (VT) are associated with higher mortality, which may be a reflection of ICD shocks being a marker of more advanced disease versus shocks causing a worse prognosis. In addition, ICD shocks are associated with decreased functional status and quality of life. Antiarrhythmic medications (AAD) reduce ICD shocks but have high rates of side effects and lack of compliance within 1 year of initiation. Some randomized, controlled clinical trials have shown that catheter ablation (CA) of VT can decrease the number of episodes of VT and ICD shocks which could translate to an improvement in patient outcomes.
Regarding the approach to CA of VT, several controversies and gaps of knowledge can be found in the literature. Some authors target predominantly "clinical VTs" (activation and entrainment mapping), while others focus on the substrate causing VTs without focusing on VT morphologies (elimination of local abnormal ventricular activities and late potentials). In addition, data on timing of the CA procedure is inconsistent. However, early CA strategy seems feasible as end-stage cardiovascular disease increases procedural risk and is associated with arrhythmias that may be less amenable to successful treatment with ablation.
The current focus on risk stratifying patients with ischemic cardiomyopathy who could benefit from a primary prevention ICD solely on basis of ejection fraction and NYHA class is far from ideal. In patients with ischemic HF, the presence of the coronary chronic total occlusion (CTO) is related to worse long-term prognosis. Moreover, in a subgroup of ischemic patients, CTO associated with a previous infarction in its territory was an independent predictor of ventricular arrhythmias. Recent studies reported that primary prevention patients with CTO of an infarct-related artery (CTO-IRA) have a very high risk of appropriate ICD therapies due to fast VTs. As post-myocardial infarction scar is a well-recognized substrate of VTs, these patients might benefit from prophylactic substrate ablation at the time of primary ICD implantation.
Eligible and consenting patients on optimal medical HF treatment with confirmed CTO-IRA will be equally randomized to receive either a primary prevention ICD or a CA procedure and an ICD. Catheter ablation with a uniform procedural endpoint and definition of acute procedural success was to be performed before ICD implantation. ICD programming will be standardized for all subjects according to primary prevention settings.
Subjects will be seen at baseline randomization, then 1 month after ICD implantation and every 6 months thereafter until the end of the study. Subjects will be followed up for a minimum of 24 months. Quality of life questionnaires will be done at each visit.
The aim of this study is to assess whether preventive substrate ablation of CTO-IRA area in HF patients correlates with lower appropriate 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
- Being tested
- Catheter ablation of ventricular tachycardia, Optimal medical treatment
- Keywords
- Ventricular Tachycardia, Ischemic Cardiomyopathy, Primary prevention, Heart Failure
- Medical subject headings
- Tachycardia, Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation of ventricular tachycardiaProcedure or surgery
Catheter ablation with a uniform mapping system, procedural endpoint, and definition of acute procedural success.
Optimal medical treatmentDrug
Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. Antiarrhythmics will be avoided if possible in the ablation group.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic VT ablation prior to ICD implantation | Experimental | Not described Receives: 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. Receives: Drug: Optimal medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Appropriate ICD therapy defined as shock or ATP therapy.
Measured: At least 24 months after enrolment
Incidence of appropriate ICD therapy
Measured: At least 24 months after enrolment
Time to unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)
Measured: At least 24 months after enrolment
Time to unplanned cardiac hospital admission
Measured: At least 24 months after enrolment
Time to electrical storm
Electrical storm defined by 3 or more sustained episodes of ventricular tachycardia (VT), ventricular fibrillation (VF), or appropriate ICD therapy within 24 hours.
Measured: At least 24 months after enrolment
Cardio-vascular mortality
Measured: At least 24 months after enrolment
Changes in quality of life using the EQ-5D questionnaire
EQ-5D is a standardised measure of health status consisting of 2 pages - the EQ-5D descriptive system (descriptive system with 3 levels) and the EQ visual analogue scale ranging from 0 (worst state) to 100 (best state).
Measured: At least 24 months after enrolment
Psychometric evaluation of ICD shock-related anxiety using The Florida Shock Anxiety Scale (FSAS)
Questions were designed to capture patient opinion on perceptions of current health status, as well as a subjective opinion of how the ICD has affected them in specific areas, including anxiety levels. A higher score indicates an positive response and a lower score indicates a negative response.
Measured: At least 24 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start6 Feb 2018
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Žižek, MD, PhD, University Medical Centre Ljubljana
- Investigators
- Matjaz Sinkovec, Prof., Study chair, University Medical Centre Ljubljana (Slovenia)Andrej Pernat, Prof., Study chair, University Medical Centre Ljubljana (Slovenia)David Zizek, Assist. Prof., Principal investigator, University Medical Centre Ljubljana (Slovenia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421834
- Sponsor's protocol ID
- PREVENTIVE VT
- Acronym
- PREVENTIVE VT
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2018
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27206819Poole 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.
PubMed 18768944Reddy 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.
PubMed 18160685Dinov 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.
PubMed 25262159Di 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.
PubMed 26718674Nombela-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.
PubMed 22205684Di 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.
PubMed 28175266Di 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.
PubMed 28675508Zizek D, Mrak M, Jan M, Zupan Meznar A, Ivanovski M, Zlahtic T, Kajdic N, Antolic B, Klemen L, Skale R, Avramovic Gregoric J, Stublar J, Pernat A, Sinkovec M. Impact of preventive substrate catheter ablation on implantable cardioverter-defibrillator interventions in patients with ischaemic cardiomyopathy and infarct-related coronary chronic total occlusion. Europace. 2024 May 2;26(5):euae109. doi: 10.1093/europace/euae109.
PubMed 38657209Kheiri 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.
PubMed 31698933
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PREVENTIVE Substrate Catheter Ablation on Implantable cardioVerter-defibrillaTor Interventions in Patients With Ischaemic Cardiomyopathy and Infarct-related Coronary Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT03421834
- Acronym / sponsor ID
- PREVENTIVE VT / PREVENTIVE VT
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Keywords
- Ventricular Tachycardia, Ischemic Cardiomyopathy, Primary prevention, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 5 Feb 2018 (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.
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.
Detailed description
Implantable cardioverter-defibrillators (ICDs) improve survival among patients with ischemic heart failure (HF) who have not previously had a sustained ventricular arrhythmia. However, ICD shocks that terminate ventricular tachycardia (VT) are associated with higher mortality, which may be a reflection of ICD shocks being a marker of more advanced disease versus shocks causing a worse prognosis. In addition, ICD shocks are associated with decreased functional status and quality of life. Antiarrhythmic medications (AAD) reduce ICD shocks but have high rates of side effects and lack of compliance within 1 year of initiation. Some randomized, controlled clinical trials have shown that catheter ablation (CA) of VT can decrease the number of episodes of VT and ICD shocks which could translate to an improvement in patient outcomes.
Regarding the approach to CA of VT, several controversies and gaps of knowledge can be found in the literature. Some authors target predominantly "clinical VTs" (activation and entrainment mapping), while others focus on the substrate causing VTs without focusing on VT morphologies (elimination of local abnormal ventricular activities and late potentials). In addition, data on timing of the CA procedure is inconsistent. However, early CA strategy seems feasible as end-stage cardiovascular disease increases procedural risk and is associated with arrhythmias that may be less amenable to successful treatment with ablation.
The current focus on risk stratifying patients with ischemic cardiomyopathy who could benefit from a primary prevention ICD solely on basis of ejection fraction and NYHA class is far from ideal. In patients with ischemic HF, the presence of the coronary chronic total occlusion (CTO) is related to worse long-term prognosis. Moreover, in a subgroup of ischemic patients, CTO associated with a previous infarction in its territory was an independent predictor of ventricular arrhythmias. Recent studies reported that primary prevention patients with CTO of an infarct-related artery (CTO-IRA) have a very high risk of appropriate ICD therapies due to fast VTs. As post-myocardial infarction scar is a well-recognized substrate of VTs, these patients might benefit from prophylactic substrate ablation at the time of primary ICD implantation.
Eligible and consenting patients on optimal medical HF treatment with confirmed CTO-IRA will be equally randomized to receive either a primary prevention ICD or a CA procedure and an ICD. Catheter ablation with a uniform procedural endpoint and definition of acute procedural success was to be performed before ICD implantation. ICD programming will be standardized for all subjects according to primary prevention settings.
Subjects will be seen at baseline randomization, then 1 month after ICD implantation and every 6 months thereafter until the end of the study. Subjects will be followed up for a minimum of 24 months. Quality of life questionnaires will be done at each visit.
The aim of this study is to assess whether preventive substrate ablation of CTO-IRA area in HF patients correlates with lower appropriate 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Optimal medical treatmentICD implantation and optimal medical care until at least 2 appropriate ICD shock occurs or an arrhythmic storm and catheter ablation thereafter. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Catheter ablation of ventricular tachycardiaCatheter ablation with a uniform mapping system, procedural endpoint, and definition of acute procedural success. | Procedure or surgery | Prophylactic VT ablation prior to ICD implantation |
| Optimal medical treatmentOptimal guidelines-based heart failure treatment and antiarrhythmic drugs. Antiarrhythmics will be avoided if possible in the ablation group. | Drug | ICD implantation and optimal medical treatment, Prophylactic VT ablation prior to ICD implantation |
Primary outcome
Time to first event comprising appropriate ICD therapy and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)
Time frame: From randomization until official study end or drop-out, patients will be followed and assessed at least 24 months.
Appropriate ICD therapy defined as shock or ATP therapy.
8 secondary outcomes
Time to appropriate ICD therapy
Time frame: At least 24 months after enrolment
Incidence of appropriate ICD therapy
Time frame: At least 24 months after enrolment
Time to unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)
Time frame: At least 24 months after enrolment
Time to unplanned cardiac hospital admission
Time frame: At least 24 months after enrolment
Time to electrical storm
Time frame: At least 24 months after enrolment
Cardio-vascular mortality
Time frame: At least 24 months after enrolment
Changes in quality of life using the EQ-5D questionnaire
Time frame: At least 24 months after enrolment
Psychometric evaluation of ICD shock-related anxiety using The Florida Shock Anxiety Scale (FSAS)
Time frame: At least 24 months after enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 27206819Ponikowski 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.
- Background: PubMed 18768944Poole 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.
- Background: PubMed 18160685Reddy 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.
- Background: PubMed 25262159Dinov 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.
- Background: PubMed 26718674Di 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.
- Background: PubMed 22205684Nombela-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.
- Background: PubMed 28175266Di 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.
- Background: PubMed 28675508Di 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.
- Derived from this study: PubMed 38657209Zizek D, Mrak M, Jan M, Zupan Meznar A, Ivanovski M, Zlahtic T, Kajdic N, Antolic B, Klemen L, Skale R, Avramovic Gregoric J, Stublar J, Pernat A, Sinkovec M. Impact of preventive substrate catheter ablation on implantable cardioverter-defibrillator interventions in patients with ischaemic cardiomyopathy and infarct-related coronary chronic total occlusion. Europace. 2024 May 2;26(5):euae109. doi: 10.1093/europace/euae109.
- Derived from this study: PubMed 31698933Kheiri 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.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Matjaz Sinkovec, Prof. study chair
University Medical Centre Ljubljana (Slovenia)
Andrej Pernat, Prof. study chair
University Medical Centre Ljubljana (Slovenia)
David Zizek, Assist. Prof. principal investigator
University Medical Centre Ljubljana (Slovenia)
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation of ventricular tachycardia and Optimal medical treatment in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by University Medical Centre Ljubljana at 5 sites in 2 countries.
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 15 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: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Slovenia, Croatia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first event comprising appropriate ICD therapy and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF) (time frame: From randomization until official study end or drop-out, patients will be followed and assessed at least 24 months.). 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 NCT03421834, which also lists 10 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 9 Jan 2024.