Reversing heparin with protamine after transfemoral TAVI

Antagonization of Heparin With Protamine Sulfate to Lower All Neurological Ischemic and Hemorrhagic Events After Transcatheter Aortic Valve Implantation for Aortic Stenosis

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: PHASE3
• Study type: Interventional
• Enrollment: 940 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Paris, Île-de-France Region)
• Trial ID: NCT06215378 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Paris, Île-de-France Region

• Pitié Salpêtrière hospital — Paris, Île-de-France Region, France (RECRUITING)

Study contacts

• Study coordinator: Paul Dr GUEDENEY, MD

Conditions: Aortic Valve Stenosis, Heart Valve Diseases, TAVI, Protamine, Heparine, Antagonization, Aortic stenosis