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

NOT_RECRUITINGPhase 2Sponsored by University Hospital, Basel, Switzerland
No longer actively recruiting
PhasePhase 2
SponsorUniversity Hospital, Basel, Switzerland
Started2022-03-16
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05145283

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

Age: 18 Years+Healthy volunteers accepted
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

Acute Ischemic StrokeAcute Renal InjuryHeart Disease

Interventions2

Conestat alfa (Ruconest®)NaCl 0,9%

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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