Status:
COMPLETED
Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
ICD
Cardiomyopathy Ischemic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Design: PARCADIA is a prospective non-randomized non-interventional multi-center clinical investigation in Europe. Patients with depressed LV (left ventricular) function assessed on local standards, o...
Detailed Description
Rationale: Implantation of an ICD as primary prevention therapy is indicated according to the current guidelines based on the low LVEF (Left Ventricular Ejection Fraction) as it was shown to significa...
Eligibility Criteria
Inclusion
- Patient with ischemic cardiomyopathy indicated for a 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
- Contraindication for MRI
- Severe renal dysfunction (stage 4 or 5) resulting in contra-indication for the admission of gadolinium during MRI (See Appendix A for more details)
- Indication for secondary prevention ICD implantation
- Class I indication for cardiac resynchronization therapy
- 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 study
- Life expectancy less than 1 year
Key Trial Info
Start Date :
July 24 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04014946
Start Date
July 24 2012
End Date
July 22 2020
Last Update
September 29 2020
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