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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.
EU CTIS ID: 2023-504511-32-00
What this study is testing
To demonstrate the superiority of systematic antagonization with protamine sulfate over usual of care to reduce in-hospital mortality, vascular/bleeding complications, stroke and TIA, myocardial infarction or red blood cell transfusion, from randomization to hospital discharge.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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
You likely can't join if
- • 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
See the full eligibility criteria
- • 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.