Clinical trials: Valve Disease, Aortic
Aortic Valve Disease
Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium (Ozaki Procedure)
The Ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root.
- Trial name
- PARACADUTE (NCT05411055)
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Maria Cecilia Hospital
Aortic Stenosis
Non-contrast 3-dimensional Cardiac Magnetic Resonance Imaging
Non-contrast enhanced cardiac MRI using 3D whole heart acquisition protocol is non-inferior to contrast enhanced CT in the assessment of aortic annulus complex for pre-TAVR imaging.
- Trial name
- NCT04496297
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Baylor Research Institute
Aortic Stenosis, Aortic Regurgitation
Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support
Transcatheter aortic valve replacement (TAVR) has a high risk and a high mortality rate in the treatment of aortic stenosis/regurgitation patients with cardiac insufficiency.
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Heart Failure With Reduced Ejection Fraction
- Trial name
- NCT04160624
- Testing
- transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Xijing Hospital
Aortic Stenosis
Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study
Currently, aortic stenosis (AS) is considered a "surgical disease" with no medical therapy available to improve any clinical outcomes, including symptoms, time to surgery, or long-term survival.
- Trial name
- ASPEN-AVR (NCT01272388)
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Cardiomyopathy, Hypertrophic Obstructive, Left Ventricular Outflow Tract Obstruction
A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
The purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects with symptomatic HCM and LVOT obstruction aged 18-70…
- Trial name
- PIONEER-HCM (NCT02842242)
- Testing
- MYK-461
- Where
- 7 sites in United States
- Volunteers
- 21 people
- Sponsor
- MyoKardia, Inc.
Hypertrophic Cardiomyopathy
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats.
- Trial name
- 3D-CMH (NCT03550573)
- Testing
- CardioInsight™ Noninvasive 3D Mapping System
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR LVAD Registry
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically…
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- JENA-VAD (NCT06594705)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Stenosis
The Pacing vs No Pacing Study - PNP Study
Pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid ventricular pacing vs valvuloplasty during…
- Trial name
- PNP (NCT02498639)
- Testing
- percutaneous balloon aortic valvuloplasty
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Aortic Stenosis
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
- Trial name
- NCT00092677
- Testing
- ezetimibe (+) simvastatin
- Volunteers
- 1,873 people
- Sponsor
- Organon and Co
Coronary Artery Disease, Valvular Heart Disease
Prehabilitation for Patients Undergoing Elective Cardiac Surgery
The objective of this clinical trial is to develop a novel rehabilitation model that, through the PRECICA program, will help to reduce perioperative and postoperative complications in the care process prior to planned cardiac…
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Chronic Thromboembolic Pulmonary Hypertension, Aortic Diseases
- Trial name
- PRECICA (NCT07704086)
- Testing
- Physical exercise, Educational program and respiration physiotherapy
- Where
- 2 sites in Spain
- Volunteers
- 86 people
- Sponsor
- Hospital Universitario 12 de Octubre
Aortic Valve Stenosis
CoreValve™ Evolut R™ FORWARD Study
Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment…
- Trial name
- FORWARD (NCT02592369)
- Testing
- Medtronic CoreValve™ Evolut R™ System
- Where
- 54 sites in Australia, Belgium and 19 more
- Volunteers
- 1,060 people
- Sponsor
- Medtronic Cardiovascular
Aortic Regurgitation
HAART Model 300 Annuloplasty Ring
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D…
- Trial name
- NCT01400841
- Testing
- HAART 300 Annuloplasty Device
- Where
- 4 sites in Belgium, Czechia and 1 more
- Volunteers
- 18 people
- Sponsor
- Biostable Science & Engineering
Aortic Valve Insufficiency
Effect of Beta Blockade on Left Ventricular Remodeling and Function in Moderate to Severe Asymptomatic Aortic Regurgitation
The primary objective of this study is to evaluate the effect of beta-blocker on left ventricular (LV) remodeling in asymptomatic patients with moderate to severe aortic regurgitation.
- Trial name
- BAR (NCT01157572)
- Testing
- Metoprolol
- Volunteers
- 75 people
- Sponsor
- Oslo University Hospital
Heart Disease Structural Disorder, Ventricular Tachycardia
Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia
Sudden cardiac death (SCD) due to recurrent ventricular tachycardia (VT) is an important clinical sequela in patients with structural heart disease.
- Conditions
- Heart Disease Structural Disorder, Ventricular Tachycardia, Cardiomyopathy, Dilated, Sarcoidosis
- Trial name
- CAAD-VT (NCT05524077)
- Testing
- Ablation, Anti-arrhythmic Drugs (AADs)
- Where
- 9 sites in Australia
- Volunteers
- 162 people
- Sponsor
- Western Sydney Local Health District
Cardiovascular Procedures, Thoracic Aortic Aneurysm
Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
- Conditions
- Cardiovascular Procedures, Thoracic Aortic Aneurysm, Aortic Valve Replacement, Type A Aortic Dissection
- Trial name
- NCT02164201
- Where
- 2 sites in Germany, Italy
- Volunteers
- 75 people
- Sponsor
- CryoLife Europa
Aortic Valve Disease, Aortic Valve Replacement
Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
In this study, the investigators will evaluate the feasibility and potential efficacy of programs to improve functional outcomes after minimally-invasive transcatheter aortic valve replacement (TAVR).
- Trial name
- OPTIMAL (NCT06106451)
- Testing
- Standard of Care plus Enhanced Patient Education, Motivational Interviewing Intervention, Home-Based Activity Program plus Motivational Interviewing Intervention
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Johns Hopkins University
Obstructive Hypertrophic Cardiomyopathy
A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
- Trial name
- NCT07021976
- Testing
- HRS-1893 Tablets
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Coronary Disease, Cardiac Valve Disease
Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis
The purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery.
- Trial name
- NCT01236313
- Testing
- TEE report
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Weill Medical College of Cornell University
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
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