Clinical trials: Aortic Valve Disease
Aortic Valve Stenosis
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs.
- Trial name
- NCT05758662
- Testing
- 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
- Where
- 4 sites in Denmark, Netherlands and 1 more
- Volunteers
- 180 people
- Sponsor
- St. Antonius Hospital
Valvular Heart Disease (Aortic and Mitral Valves)
Phase Contrast in Valvular Heart Disease
The ability to quantify flow directly using through-plane phase contrast velocity mapping is a unique advantage of cardiovascular magnetic resonance and does not rely on the calculation from complex equations as echocardiography.
- Trial name
- NCT03669666
- Where
- Egypt
- Volunteers
- 35 people
- Sponsor
- Assiut University
Intellectual Disability, Neurodevelopmental Disorders
Physical Activity and Community EmPOWERment Project
Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease…
- Conditions
- Intellectual Disability, Neurodevelopmental Disorders, Autism Spectrum Disorder, Down Syndrome
- Trial name
- PACE (NCT06740162)
- Testing
- PACE Program
- Where
- 2 sites in United States
- Volunteers
- 376 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Hypertrophic Cardiomyopathy
CVD Risk Profile in Children With HCM
Hypertrophic cardiomyopathy is a disease of the heart muscle that causes the heart to become thicker and this thickness places children at risk of heart rhythm problems, heart failure and sudden death.To decrease the risk of…
- Trial name
- NCT05510180
- Where
- 10 sites in Canada
- Volunteers
- 56 people
- Sponsor
- University of Alberta
Aortic Valve Stenosis
PremiCron Suture for Cardiac Valve Repair
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
- Trial name
- PremiValve (NCT04096859)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 198 people
- Sponsor
- Aesculap AG
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV EU-EFS
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical…
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure
- Trial name
- NCT06510855
- Testing
- DurAVR™ THV System
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Atrial Fibrillation, Valve Heart Disease
Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Atrial Fibrillation Associated With Valvular Disease
The prevalence of AF, which is tachyarrhythmia, is approximately 2% of the entire population and 5% of the population at the age of 60 or older.
- Trial name
- DECISIVE (NCT02982850)
- Testing
- Dabigatran, Acetylsalicylic acid, Warfarin
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- Asan Medical Center
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.
- Trial name
- PERFECT (NCT07343674)
- Where
- 12 sites in Portugal
- Volunteers
- 500 people
- Sponsor
- Portuguese Association of Interventional Cardiology
Severe Aortic Valve Stenosis
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient…
- Trial name
- VRAP-Heart (NCT05552352)
- Testing
- Virtual Reality assisted information
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Coronary Arteriosclerosis
Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery
This study is a randomized open label study that implies the administration of asprin according to three different regimens. The aims of the study are: to establish whether coronary artery bypass surgery and / or aortic valve…
- Trial name
- ASABYVALV (NCT01466452)
- Testing
- Aspirin
- Where
- Italy
- Volunteers
- 99 people
- Sponsor
- Centro Cardiologico Monzino
Heart Valve Disease
The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery
Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction.
- Trial name
- NCT01210976
- Testing
- levosimendan
- Where
- Finland
- Volunteers
- 24 people
- Sponsor
- Tampere University Hospital
Pulse Wave, Aortic Stenosis
Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis
Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in…
- Trial name
- VOPRABIO (NCT03140735)
- Testing
- Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction, Control group without heart disease
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire, Amiens
HOCM, Hypertrophic Obstructive Cardiomyopathy
CRyo-Ablation to Treat Patients With HOCM.
The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the LVOT obstruction in patients with Hypertrophic Obstructive Cardiomyopathy.
- Trial name
- CRASH (NCT01875016)
- Testing
- CRyo-Ablation to Treat HOCM.
- Volunteers
- 15 people
- Sponsor
- Shaare Zedek Medical Center
Hypertrophic Cardiomyopathy, Heart Failure
Empagliflozin in Hypertrophic Cardiomyopathy
The proposed intervention will be administration of empagliflozin at a standard dose of 10 mg daily for a period of 12 months. Patients with diagnosed diabetes will be excluded from the study.
- Trial name
- EMPA-REPAIR (NCT05182658)
- Testing
- Empagliflozin 10 MG
- Where
- 2 sites in Poland
- Volunteers
- 250 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Hypertrophic Cardiomyopathy (HCM), Heart Failure
Retrospective Natural History Study of RASopathy-associated Cardiomyopathy (RAS-CM)
RASopathy-associated hypertrophic cardiomyopathy (RAS-CM) is a disease with high morbidity and high mortality if presenting during infancy.
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Heart Failure, RASopathy
- Trial name
- RAS-CM (NCT07344480)
- Testing
- Retrospective data collection
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Left Bundle-Branch Block, Aortic Stenosis
Study on Heart Block Risks Using Outcome-Based Modeling
This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis…
- Trial name
- SAVIOR (NCT07065123)
- Testing
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Severe Aortic Valve Stenosis, Cardiovascular Diseases
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential…
- Trial name
- IMPROVE (NCT07456280)
- Testing
- Standard care, PhysioMem PM 100 4G ambulatory monitoring system
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Aortic Stenosis, Ascending Aortic Dilatation
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.
- Trial name
- NCT06743568
- Testing
- Transcatheter aortic valve replacement
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Atrial Fibrillation, Atrial Flutter
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Venous Thromboembolic Disease, Myocardial Infarction
- Trial name
- EmbraceAC (NCT00691470)
- Testing
- ATI-5923, Coumadin (warfarin)
- Where
- 41 sites in United States
- Volunteers
- 600 people
- Sponsor
- ARYx Therapeutics