RecruitingNot ApplicableNCT04576130

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

A Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillator in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation Who Receive Complete Revascularization


Sponsor

Rigshospitalet, Denmark

Enrollment

1,200 participants

Start Date

Oct 12, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

DanICD is a randomized, controlled study to with the aim to assess whether there is a benefit of ICD-implantation in patients with coronary artery disease (including acute myocardial infarction), who survive cardiac arrest due to ventricular fibrillation/sustained ventricular tachycardia and undergo revascularization and with an LVEF above 35%.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients with CAD and cardiac arrest due to VF/VT, where angiogram is performed with complete revascularization (PCI, CABG or hybrid coronary revascularization) before ICD implantation. Unfavorable artery for PCI (i.e., excessive vessel tortuosity or chronic total occlusion) or high-risk invasive treatment is not mandatory in order to achive complete revascularization.
  • Age ≥18 years
  • LVEF >35% at the time of discharge. The most recent LVEF assessment on which the current medical treatment will be based at the time of entry into the study will be used as baseline LVEF.

Exclusion Criteria5

  • Non-ischemic cause of cardiac arrest (i.e. ion channel diseases, non-ischemic cardiomyopathy)
  • Previous CABG within the last 3 months before index hospitalization
  • Life expectancy less than 1 year or severe neurologic outcome
  • Unable or unwilling to give informed consent
  • Pregnancy

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Interventions

DEVICEImplantable cardioverter defibrillator

Implantation of an ICD for secondary prevention


Locations(1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

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NCT04576130


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