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

January 6, 2024 updated by: David Žižek, MD, PhD, University Medical Centre Ljubljana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Croatia
      • Zagreb, Croatia, HR-10000
        • Klinički Bolnički Centar Sestre Milosrdnice
  • Slovenia
      • Celje, Slovenia, 3000
        • General Hospital Celje
      • Izola, Slovenia, 6310
        • General Hospital Izola
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana - Cardiology department
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana - Cardiovascular surgery department

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ischemic cardiomyopathy with reduced ejection fraction (EF ≤ 40%) estimated by cardiac MRI or echocardiography within 30 days before enrollment
  2. 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
  3. Implantable cardioverter-defibrillator (ICD) indication for primary prevention
  4. Patient has provided written informed consent

Exclusion Criteria:

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

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: Prophylactic VT ablation prior to ICD implantation
Procedure: Catheter ablation of ventricular tachycardia
Catheter ablation with a uniform mapping system, procedural endpoint, and definition of acute procedural success.
Drug: Optimal medical treatment
Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. Antiarrhythmics will be avoided if possible in the ablation group.
Active Comparator: ICD implantation and optimal medical treatment
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
Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. Antiarrhythmics will be avoided if possible in the ablation group.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to appropriate ICD therapy
Time Frame: At least 24 months after enrolment
Appropriate ICD therapy defined as shock or ATP therapy.
At least 24 months after enrolment
Incidence of appropriate ICD therapy
Time Frame: At least 24 months after enrolment
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
At least 24 months after enrolment
Time to unplanned cardiac hospital admission
Time Frame: At least 24 months after enrolment
At least 24 months after enrolment
Time to electrical storm
Time Frame: At least 24 months after enrolment
Electrical storm defined by 3 or more sustained episodes of ventricular tachycardia (VT), ventricular fibrillation (VF), or appropriate ICD therapy within 24 hours.
At least 24 months after enrolment
Cardio-vascular mortality
Time Frame: At least 24 months after enrolment
At least 24 months after enrolment
Changes in quality of life using the EQ-5D questionnaire
Time Frame: At least 24 months after enrolment
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).
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
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.
At least 24 months after enrolment

Collaborators and Investigators

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

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Matjaz Sinkovec, Prof., University Medical Centre Ljubljana (Slovenia)
  • Study Chair: Andrej Pernat, Prof., University Medical Centre Ljubljana (Slovenia)
  • Principal Investigator: David Zizek, Assist. Prof., University Medical Centre Ljubljana (Slovenia)

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)

February 6, 2018

Primary Completion (Actual)

January 4, 2024

Study Completion (Actual)

January 4, 2024

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENTIVE VT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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