ATLANTIS Protamine - Antagonization of heparin with protamine sulfate to reduce all neurologic ischemic and hemorrhagic events after transcatheter aortic valve implantation for aortic stenosis: the ATLANTIS Protamine study.
- Conditions
- Any patients =18 years old, eligible for transfemoral TAVI with coverage for medical insuranceMedDRA version: 20.0Level: PTClassification code: 10007649Term: Cardiovascular disorder Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-504511-32-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 940
•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
•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, •Pregnancy and breast feeding women, •Contemporaneous enrolment in an interventional clinical trial, •Patient under guardianship or curatorship, •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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method