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Clinical Trials/NL-OMON40036
NL-OMON40036
Completed
Not Applicable

Prospective Assessment of Risk Factors for Appropriate ICD Intervention in Patients with Ischemic Cardiomyopathy . - PARCADIA

Biotronik0 sites200 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
disease of the heart muscle
Sponsor
Biotronik
Enrollment
200
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Sponsor
Biotronik

Eligibility Criteria

Inclusion Criteria

  • \*Patient with ischemic cardiomyopathy with an indication for de novo ICD implantation for primary prevention, according to ESC guidelines or local standards (MADIT II population)
  • \*Written informed consent / willingness and ability to comply with the protocol

Exclusion Criteria

  • \*Contraindication for MRI
  • \*Severe renal dysfunction (if leading to a contraindication for the admission of Gadolinium with MRI)
  • \*Indication for secondary prevention ICD implantation
  • \*Class I indication for CRT\-D
  • \*Heart failure with New York Heart Association functional class IV
  • \*LV ejection fraction \>40%
  • \*Age \<18 years and \>85 years
  • \*Women that are pregnant, lactating or planning to become pregnant
  • \*Participating in any other clinical trial with active intervention(s) during the course of this clinical investigation
  • \*Life expectancy less than 1 year

Outcomes

Primary Outcomes

Not specified

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