Status:
RECRUITING
Antagonization of Heparin With Protamine Sulfate After TAVI
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Action Research Group
Conditions:
Aortic Valve Stenosis
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Transcatheter aortic valve replacement (TAVR) is now the first therapeutic option offered to high and intermediate risk patients with symptomatic aortic stenosis but even to low-risk, when the aortic ...
Eligibility Criteria
Inclusion
- Men and women ≥18 years of age
- Any patient eligible for transfemoral TAVI, irrespective of the chronic antithrombotic treatment
- Written informed consent
- Registered at the French social healthcare
Exclusion
- Any major protamine sulfate exposure contraindications defined as a history of severe pulmonary hypertension, acute pulmonary edema or history of bronchospasm related to protamine sulfate administration
- Known allergy to protamine sulfate
- Hypersensitivity to protamine sulfate including protamine contained as an excipient in NPH \[Neutral Protamine Hagedorn\] insulin, known protamine or protamine-heparine complex antibodies
- Non-femoral approach for the TAVI procedure
- Protamine sulfate exposure within 24h of randomization
- Fish allergy
- Mechanical valves
- For men: Sterile or Vasectomy
- Women of childbearing potential
- Pregnancy and breast feeding women
- Contemporaneous enrolment in an interventional clinical trial
- Patient under guardianship or curatorship
Key Trial Info
Start Date :
May 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
940 Patients enrolled
Trial Details
Trial ID
NCT06215378
Start Date
May 25 2025
End Date
March 1 2027
Last Update
August 22 2025
Active Locations (1)
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1
Pitié Salpêtrière hospital
Paris, Île-de-France Region, France, 75013