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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Pharming Technologies B.V.; Swiss National Science Foundation
• Treatments: Complement C1 Inhibitor Protein

Criteria

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