Transcatheter aortic valve implantation – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Thu, 28 May 2026 11:26:21 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Transcatheter aortic valve implantation – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study on Protamine Sulfate for Reducing Bleeding and Ischemic Events in Adults with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement https://clinicaltrials.eu/trial/study-on-protamine-sulfate-for-reducing-bleeding-and-ischemic-events-in-adults-with-severe-aortic-stenosis-undergoing-transcatheter-aortic-valve-replacement/ Wed, 29 Apr 2026 15:03:19 +0000 https://clinicaltrials.eu/trial/study-on-protamine-sulfate-for-reducing-bleeding-and-ischemic-events-in-adults-with-severe-aortic-stenosis-undergoing-transcatheter-aortic-valve-replacement/ 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.

]]> Study on the Effects of Apixaban, Acetylsalicylic Acid, and Rivaroxaban on Heart Valve Thickening in Patients with Aortic Valve Replacement https://clinicaltrials.eu/trial/study-on-the-effects-of-apixaban-acetylsalicylic-acid-and-rivaroxaban-on-heart-valve-thickening-in-patients-with-aortic-valve-replacement/ Wed, 29 Apr 2026 14:58:01 +0000 https://clinicaltrials.eu/trial/study-on-the-effects-of-apixaban-acetylsalicylic-acid-and-rivaroxaban-on-heart-valve-thickening-in-patients-with-aortic-valve-replacement/ The Nordic Aortic Valve Intervention Trial 4 (NOTION-4) is a clinical study focused on patients who have undergone a successful procedure known as *transcatheter aortic valve implantation* (TAVI). This procedure involves placing a new valve in the heart without removing the old, damaged valve. The study aims to explore the effects of different *anti-thrombotic therapies* on a condition called *subclinical leaflet thickening* in the new valve. Subclinical leaflet thickening, also known as HALT, refers to a situation where the leaflets of the valve become thicker without causing noticeable symptoms. This condition is assessed using a special imaging technique called *cardiac CT*.

The study involves several medications, including *Apixaban*, *Acetylsalicylic Acid* (commonly known as aspirin), *Rivaroxaban*, *Dabigatran Etexilate*, *Edoxaban*, *Clopidogrel*, and *Warfarin Sodium*. These medications are used to prevent blood clots, which can be a concern after valve replacement procedures. Participants in the study are randomly assigned to receive one of these medications or a placebo. The purpose of the study is to understand how these medications affect the thickening of the valve leaflets over time.

Throughout the study, participants will undergo regular check-ups and imaging tests to monitor the condition of their heart valves. The study will track the number of patients experiencing leaflet thickening at various intervals, such as 3 months, 1 year, 3 years, and 5 years after the TAVI procedure. Additionally, the study will observe any related health events, such as strokes or bleeding, and assess overall health outcomes like mortality and quality of life. The study is expected to continue until 2030, providing valuable insights into the long-term effects of different anti-thrombotic treatments on heart valve health.

]]> Study on Sedation During Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis Using Remifentanil, Dexmedetomidine, and Propofol https://clinicaltrials.eu/trial/study-on-sedation-during-transcatheter-aortic-valve-replacement-in-patients-with-aortic-stenosis-using-remifentanil-dexmedetomidine-and-propofol/ Wed, 29 Apr 2026 14:27:49 +0000 https://clinicaltrials.eu/trial/study-on-sedation-during-transcatheter-aortic-valve-replacement-in-patients-with-aortic-stenosis-using-remifentanil-dexmedetomidine-and-propofol/ This clinical trial is focused on studying the effects of different medications used for sedation during a procedure called Transcatheter Aortic Valve Replacement (TAVR). TAVR is a treatment for patients with aortic stenosis, a condition where the heart’s aortic valve becomes narrowed, affecting blood flow. The medications being studied include Remifentanil, Dexmedetomidine, Propofol, and Ketamine. These medications are used to help patients relax and feel comfortable during the procedure.

The purpose of the study is to determine if there are differences in the occurrence of certain conditions during and after the procedure, such as respiratory acidosis and emergence delirium. Respiratory acidosis is a condition where there is too much carbon dioxide in the blood, and emergence delirium is a state of confusion that can occur after waking up from sedation. The study will compare how often these conditions occur with each medication.

Participants in the study will receive one of the medications during their TAVR procedure. The study will monitor their condition during the procedure and for 24 hours afterward to check for any signs of respiratory acidosis or emergence delirium. The study aims to provide valuable information on the safety and effectiveness of these sedation medications during TAVR procedures.

]]> Study on Iron Infusion with Ferric Carboxymaltose for Elderly Patients with Severe Aortic Stenosis and Iron Deficiency Undergoing TAVI https://clinicaltrials.eu/trial/study-on-iron-infusion-with-ferric-carboxymaltose-for-elderly-patients-with-severe-aortic-stenosis-and-iron-deficiency-undergoing-tavi/ Wed, 29 Apr 2026 14:25:49 +0000 https://clinicaltrials.eu/trial/study-on-iron-infusion-with-ferric-carboxymaltose-for-elderly-patients-with-severe-aortic-stenosis-and-iron-deficiency-undergoing-tavi/ This clinical trial is focused on studying the effects of an iron infusion treatment in elderly patients who have a condition called Aortic Stenosis and are also experiencing Iron Deficiency. Aortic stenosis is a heart condition where the valve that controls blood flow from the heart to the rest of the body becomes narrowed, making it difficult for the heart to pump blood. Iron deficiency occurs when the body does not have enough iron, which is essential for producing healthy red blood cells. The treatment being tested in this study is called Ferinject, which contains a substance known as Ferric Carboxymaltose. This is a type of iron given through an injection or infusion directly into the bloodstream.

The purpose of the study is to determine if this iron treatment can improve the quality of life and exercise capacity in patients who are undergoing a procedure called Transcatheter Aortic Valve Implantation (TAVI). TAVI is a minimally invasive procedure used to replace the narrowed aortic valve. Participants in the study will receive either the iron treatment or a placebo. Over the course of the study, participants will be monitored for changes in their quality of life, ability to exercise, and cognitive function, which refers to mental processes like thinking and memory.

The study will last for several months, during which participants will undergo various assessments, including questionnaires and a walking test, to evaluate their progress. The main goal is to see if the iron treatment can help improve the overall well-being and physical abilities of those with severe aortic stenosis and iron deficiency. The results will help determine if this treatment could be beneficial for similar patients in the future.

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