Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04576130

A Danish Study to Assess the Benefit of Implantable Cardioverter Defibrillators in Patients with Coronary Artery Disease and Ventricular Fibrillation After Complete Revascularization

Led by Rigshospitalet, Denmark · Updated on 2025-01-27

1200

Participants Needed

1

Research Sites

624 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the benefit of implanting an implantable cardioverter defibrillator (ICD) in patients with coronary artery disease who have survived cardiac arrest caused by ventricular fibrillation or sustained ventricular tachycardia. These patients have undergone revascularization procedures and have a left ventricular ejection fraction (LVEF) above 35%. The study aims to assess whether ICD implantation improves outcomes in this specific group. Participants are randomly assigned to receive ICD implantation as a device-based secondary prevention measure. The study includes patients who had complete revascularization through procedures such as PCI, CABG, or hybrid coronary revascularization before receiving the ICD. The study is designed to compare outcomes between those who receive the ICD and those who do not, focusing on long-term effects. During the study, participants are monitored for all-cause mortality over a 5-year period. Researchers will track survival rates and assess the overall benefit of ICD implantation in this patient population. The study involves follow-up assessments to evaluate health status and any adverse events, ensuring comprehensive safety monitoring throughout the participation period.

CONDITIONS

Official Title

A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with coronary artery disease and cardiac arrest due to ventricular fibrillation or sustained ventricular tachycardia, who underwent angiogram with complete revascularization (PCI, CABG, or hybrid coronary revascularization) before ICD implantation
  • Age 18 years or older
  • Left ventricular ejection fraction (LVEF) greater than 35% at the time of discharge, based on the most recent assessment
Not Eligible

You will not qualify if you...

  • Cardiac arrest due to non-ischemic causes (such as ion channel diseases or non-ischemic cardiomyopathy)
  • Previous coronary artery bypass graft (CABG) surgery within 3 months before the current hospitalization
  • Life expectancy less than 1 year or severe neurological damage
  • Unable or unwilling to give informed consent
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Actively Recruiting

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Research Team

R

Reza Jabbari, MD, PhD

T

Thomas Engstrøm, MD, PhD, DMSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Frequently Asked Questions

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A Danish Study to Assess the Benefit of Implantable Cardioverter Defibrillators in Patients with Coronary Artery Disease and Ventricular Fibrillation After Complete Revascularization | DecenTrialz