Assessment of Blood Clotting and Bleeding Risks After Transcatheter Aortic Valve Replacement TAVR by Surgical Risk and Treatment Type
Led by Niguarda Hospital · Updated on 2026-04-16
2500
Participants Needed
12
Research Sites
110 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are assessing the risks of blood clots ischemic events and bleeding after transcatheter aortic valve replacement TAVR in patients with severe aortic stenosis. This study focuses on how different antithrombotic therapies and surgical risk levels affect these risks. It also explores how the type of valve prosthesis and blood count factors like hemoglobin and platelets influence daily ischemic and bleeding risks over time. The aim is to improve personalized treatment strategies after TAVR.
Participants will be grouped based on their surgical risk low, intermediate, or high and the antithrombotic therapy they receive, such as single or dual antiplatelet therapy, oral anticoagulation, or combinations. The study observes changes in antithrombotic treatments at 1 month, 90 days, and 1 year following TAVR. It also examines the impact of prosthesis characteristics and blood abnormalities on risk events using repeated-event analysis.
During the study, participants ischemic and bleeding risks will be tracked at 30 days, 90 days, and 1 year after the procedure. Researchers will monitor therapy adjustments, the timing and type of changes, and collect data on anemia and low platelet counts. The study evaluates these outcomes to understand how risks fluctuate over time and how personalized antithrombotic strategies might better manage patients after TAVR.
CONDITIONS
Brief Title
Ischemic And Bleeding Risk Assessment After TAVR
Research Team
G
Giuseppe Esposito, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
All patients with severe aortic stenosis undergoing TAVR.
Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.
You will not qualify if you...
Patients who died during the index procedure.
Patients in triple antithrombotic therapy at discharge.
Patients with a known prognosis less than 1 year at the time of TAVR.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 1 year
Participants who undergo routine care after TAVR are observed to assess ischemic and bleeding risks based on surgical risk level and antithrombotic therapy.
Assessments at 30 days, 90 days, and 1 year
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Developing a 10-Minute MRI Protocol to Improve Heart Disease Diagnosis and Care
Study to Collect CT and Heart Echo Imaging Data Before and After Transcatheter Aortic Valve Implantation TAVI to Predict Valve Performance
Safety and Effectiveness of the Edwards SAPIEN X4 Balloon-Expandable Transcatheter Heart Valve in Patients With Failing Aortic Bioprosthetic Valves
Study of Angiotensin Receptor Blockers to Slow Progression of Mild to Moderate Aortic Stenosis and Improve Heart Function
Heparin Reversal With Protamine Sulfate to Reduce Complications After Transcatheter Aortic Valve Replacement for Aortic Stenosis
Comparing Transcatheter and Surgical Aortic Valve Replacement in Patients Over 50 with Severe Aortic Valve Narrowing and Bicuspid Valve
Study Comparing Strict Versus Conventional Blood Pressure Control in Adults with Asymptomatic Moderate to Severe Aortic Valve Stenosis
Study of EmStop Embolic Protection System Compared to Sentinel Device
for Safety and Effectiveness During Transcatheter Aortic Valve Replacement
in Adults with Severe Aortic Valve Stenosis
CardioHeartConnect Mobile Cardiac Rehabilitation Using Peloton for Patients Recovering From Transcatheter Aortic Valve Replacement
Clinical Outcomes and Valve Performance After Transcatheter Aortic Valve Replacement in Adults with Severe Aortic Valve Disease
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Catherine M Otto, Rick A Nishimura, Robert O Bonow...