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New treatment option for Aortic Valve Stenosis
Official title Antagonization of Heparin With Protamine Sulfate After TAVI
ClinicalTrials.gov ID: NCT06215378
What this study is testing
What is Antagonization of heparin with protamine sulfate?
Antagonization of heparin with protamine sulfate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for aortic valve stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 valve is tricuspid and the transfemoral approach is suitable. Vascular and bleeding complications are the most frequent procedure-related unwanted events associated with increased short-term morbidity and mortality.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Known allergy to protamine sulfate
- Hypersensitivity to protamine sulfate including protamine contained as an excipient in NPH [Neutral Protamine Hagedorn] insulin, known protamine or...
- Non-femoral approach for the TAVI procedure
- Protamine sulfate exposure within 24h of randomization
- Fish allergy
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
- 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 treatment clinical trial
- Patient under guardianship or curatorship
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Île-de-France Region, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.