Reversing heparin with protamine after transfemoral TAVI
Official title: Antagonization of Heparin With Protamine Sulfate to Lower All Neurological Ischemic and Hemorrhagic Events After Transcatheter Aortic Valve Implantation for Aortic Stenosis
Run by Assistance Publique - Hôpitaux de Paris · NCT06215378 · Data updated 2026-11-12
This trial tries giving protamine to reverse heparin right after transfemoral TAVI in adults to see if it reduces bleeding and vascular complications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 940 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Status | Recruiting |
| Started | May 25, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | August 22, 2025 |
| Trial ID | NCT06215378 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) eligible for transfemoral TAVI who can give written consent and are registered in the French social healthcare system are eligible, regardless of chronic antithrombotic therapy.
✕Probably not a fit
Patients with contraindications to protamine (including severe pulmonary hypertension, protamine allergy, recent protamine exposure), non-femoral TAVI approaches, pregnant or breastfeeding women, or those with mechanical valves are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial tests antagonization of procedural heparin with protamine sulfate in adults undergoing transfemoral transcatheter aortic valve implantation (TAVI) at a French tertiary center. Patients eligible for transfemoral TAVI who provide consent and are registered in the French social healthcare system are enrolled, while those with known protamine contraindications or non-femoral approaches are excluded. The protocol follows standard intraprocedural anticoagulation practices (ACT target ≈300 seconds) and administers protamine post-procedure to reverse heparin activity, with safety and bleeding/vascular complication outcomes captured. The sponsor is Assistance Publique - Hôpitaux de Paris and the trial is conducted at Pitié Salpêtrière hospital in Paris.
Why it matters
Potential benefit: If successful, routine protamine reversal could lower procedure-related bleeding and vascular complications and reduce short-term morbidity after transfemoral TAVI.
How similar studies have gone: Observational and smaller interventional reports have suggested protamine can reduce bleeding in some TAVI and surgical settings, but randomized Phase 3 evidence is limited and heterogeneous.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where it's running
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Pitié Salpêtrière hospital
Paris, Île-de-France Region, France Recruiting
Study contacts
- Study coordinator: Paul Dr GUEDENEY, MD
- Email: paul.guedeney@aphp.fr
- Phone: 0184827619
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.