Study on Protamine Sulfate for Reducing Bleeding and Ischemic Events in Adults with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

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What is this study about?

This clinical trial is focused on patients with severe aortic stenosis, a condition where the heart’s aortic valve narrows, affecting blood flow. These patients are scheduled to undergo a procedure called transcatheter aortic valve replacement (TAVR), which is a minimally invasive method to replace the narrowed valve. The study will use a treatment called protamine sulfate, which is a medication used to reverse the effects of another drug called heparin, often used during surgeries to prevent blood clots.

The purpose of the study is to evaluate the benefits of using protamine sulfate after the TAVR procedure, specifically looking at its impact on reducing major bleeding and major ischemic events, which are serious conditions where blood flow to the heart or brain is reduced. Participants in the study will receive either protamine sulfate or a placebo after their TAVR procedure. The study will monitor the participants for any bleeding or ischemic events for up to 60 hours after the procedure.

Throughout the study, researchers will also observe other outcomes, such as the rate of mortality in the hospital, any additional surgeries needed, and the overall recovery of the heart valve function. The study aims to provide valuable information on the safety and effectiveness of protamine sulfate in improving outcomes for patients undergoing TAVR. This research is expected to continue until early 2027, with recruitment starting in 2025.

1 joining the study

The study involves adult patients aged 55 years or older with severe aortic stenosis who are scheduled for a procedure called transfemoral transcatheter aortic valve replacement (TAVR).

Participants must be willing to participate, able to understand the study, and have signed an informed consent form.

2 procedure preparation

Before the TAVR procedure, participants will be prepared according to standard medical protocols.

This preparation may include routine tests and assessments to ensure readiness for the procedure.

3 TAVR procedure

The TAVR procedure is performed to replace the aortic valve without open-heart surgery.

During this procedure, a new valve is inserted through a blood vessel in the leg.

4 administration of <b>protamine sulfate</b>

After the TAVR procedure, protamine sulfate is administered to reverse the effects of heparin, a medication used during the procedure to prevent blood clots.

The protamine sulfate is given as an intravenous bolus, which means it is injected directly into a vein in a single, quick dose.

5 post-procedure monitoring

Participants are monitored for 60 hours after the TAVR procedure to assess for any bleeding or major ischemic events, such as heart attacks or strokes.

Monitoring includes checking for bleeding, measuring the aortic valve gradient using echocardiography, and observing for any signs of valve thrombosis.

6 follow-up assessments

Follow-up assessments are conducted to evaluate outcomes such as mortality, any unplanned surgeries, and changes in heart function.

These assessments occur at various intervals, including 30 days after the TAVR procedure.

7 study completion

The study is expected to continue until February 28, 2027.

Participants will be informed of the study’s findings and any relevant information regarding their health.

Who Can Join the Study?

Must be 55 years or older.
Have severe aortic stenosis, which means a serious narrowing of the heart’s aortic valve.
Scheduled for a transfemoral TAVR, a procedure to replace the aortic valve through a blood vessel in the leg.
Willing to participate, able to understand the study, and have signed an informed consent, which is a document that explains the study and confirms your agreement to join.

Who Cannot Join the Study?

Patients who are not adults. This means anyone under 18 years old cannot participate.
Patients who do not have severe aortic stenosis. Aortic stenosis is a condition where the heart’s aortic valve narrows, affecting blood flow.
Patients who are not scheduled for a procedure called transfemoral TAVR. TAVR stands for Transcatheter Aortic Valve Replacement, a procedure to replace the aortic valve without open-heart surgery.
Patients who are part of a vulnerable population. This refers to groups who may need special protection, like pregnant women or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria

Other Sites

Site Name	City	Country
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen	Munich	Germany
Uagynrzkweikmirteagyv Ametwhay	Augsburg	Germany
Kvxutyze dxk Ufqtvipqioir Mgmwdbji Ajw	Munich	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.01.2025
Germany	Recruiting	01.01.2025

Trial locations

Investigated drugs:

Protamine Sulfate

Protamine is used in this clinical trial to reverse the effects of heparin after a transcatheter aortic valve replacement procedure. Heparin is a medication that helps prevent blood clots, but after the procedure, it is important to stop its action to reduce the risk of bleeding. Protamine helps to neutralize heparin, thereby reducing the risk of major bleeding and ischemic events, which are conditions where blood flow (and thus oxygen) is restricted or reduced in a part of the body.

Aortic Stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed, restricting blood flow from the heart to the rest of the body. Over time, this narrowing can lead to increased pressure within the heart, causing the heart muscle to thicken and potentially weaken. Symptoms may include chest pain, fatigue, shortness of breath, and fainting, especially during physical activity. As the condition progresses, it can lead to heart failure and other complications. The severity of symptoms often correlates with the degree of valve narrowing. Treatment typically involves procedures to repair or replace the affected valve.

Trial ID:

2024-512024-10-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Protamine Sulfate for Reducing Bleeding and Ischemic Events in Adults with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?