Clinical trials: Stenoses, Aortic
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Trial name
- Neo2BAV (NCT06212050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Germany, Ireland and 1 more
- Volunteers
- 200 people
- Sponsor
- National University of Ireland, Galway, Ireland
Aortic Valve Stenosis
Concentration of Plant Sterols in Serum and Aortic Valve Cusps
This study investigates the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations of plant sterols.
- Trial name
- NCT00222950
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital, Saarland
Cardiomegaly
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy
The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk pathway that lead to MEK activation, would be…
- Trial name
- NCT01556568
- Testing
- MEK162
- Where
- 2 sites in United States, United Kingdom
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Coronary Artery Disease., Aortic Valve Stenosis.
Cerebral Oxymetry at Elective Coronary and Valve Surgery.
Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.
- Conditions
- Coronary Artery Disease., Aortic Valve Stenosis., Aortic Valve Regurgitation.
- Trial name
- Co-HLM (NCT01940874)
- Where
- Norway
- Volunteers
- 54 people
- Sponsor
- Oslo University Hospital
Severe Aortic Stenosis, Transcatheter Aortic Valve Implantation
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI
This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy…
- Trial name
- CT-CA (NCT03291925)
- Testing
- Selective invasive angiography based on CT/CCTA imaging., Procedure/Surgery: Invasive angiography
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Aortic Stenosis, Anxiety
10-year Follow-up After Aortic Valve Replacement Surgery
There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient…
- Conditions
- Aortic Stenosis, Anxiety, Depressive Symptoms, Quality of Life
- Trial name
- AVR-10year (NCT06255691)
- Volunteers
- 282 people
- Sponsor
- Oslo University Hospital
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
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
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
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