Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation

Summary

The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS) compared to placebo.

Eligibility

Inclusion Criteria:

* Informed consent as documented by signature
* Severe AS and scheduled for transfemoral TAVI

Exclusion Criteria:

* Contraindications to the class of drugs under study (C1INH), e.g., known hypersensitivity or allergy to class of drugs or the investigational product
* History of allergy to rabbits (as rhC1INH is derived from the breast milk of transgenic rabbits)
* Women who are pregnant or breast feeding
* Hemodynamic instability requiring emergency TAVI
* Valve-in-valve procedure
* Other access route than transfemoral
* Non-cardiac co-morbidity with expected survival \<6 months
* Ischemic or hemorrhagic stroke within 30 days before TAVI
* Dialysis or estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73m2
* Contraindication for MRI such as a permanent non-MRI compatible pacemaker or severe claustrophobia
* Liver cirrhosis (any Child-Pugh score)
* Incapacity or inability to provide informed consent
* Participation in another study with investigational drug or medical device within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Any uncontrolled or significant concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements at the discretion of the investigator

Conditions3

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