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

NCT03421834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Matjaz Sinkovec, Prof. · University Medical Centre Ljubljana (Slovenia)

  • Andrej Pernat, Prof. · University Medical Centre Ljubljana (Slovenia)

  • David Zizek, Assist. Prof. · University Medical Centre Ljubljana (Slovenia)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2024-01-04
Completion
2024-01-04

Countries

  • Croatia
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421834 on ClinicalTrials.gov