Clinical trials: Cardiac Valve Disease
Aortic Valve Disease
Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic…
- Trial name
- NCT00677638
- Testing
- Ventor Embracer
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Ventor Technologies
Severe Symptomatic Aortic Stenosis
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have…
- Trial name
- Inop AA (NCT01787084)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve
- Volunteers
- 8 people
- Sponsor
- The Society of Thoracic Surgeons
Aortic Stenosis
General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement
Transcarotid transcatheter aortic valve replacement (Transcarotid TAVR) has been increasingly used as an alternative to the transfemoral approach.
- Trial name
- GALATTAVI (NCT06870734)
- Volunteers
- 44 people
- Sponsor
- University Hospital, Caen
Aortic Valve Disease, Aortic Valve Stenosis
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT06518681
- Testing
- PoliaValve (Aortic)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Coronary Artery Disease, Postoperative Complications
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery
This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery.
- Conditions
- Coronary Artery Disease, Postoperative Complications, Aortic Valve Stenosis, Mitral Valve Disease
- Trial name
- PREFER-CABG (NCT03574311)
- Testing
- Ferric carboxymaltose, Physiological saline
- Where
- Finland
- Volunteers
- 210 people
- Sponsor
- Turku University Hospital
Aortic Valve Disease, Aortic Valve Stenosis
PERCEVAL S Valve Clinical Study for Chinese Registration
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased…
- Trial name
- PERFECT (NCT03481387)
- Testing
- Aortic Valve Replacement with Perceval S sutureless heart valve
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Corcym S.r.l
Hypertrophic Cardiomyopathy
Use of Magnetic Field Mapping in the Evaluation of Patients With Hypertrophic Heart Disease (Thick Heart Muscle)
The purpose of this research study is to further establish the diagnostic use of magnetocardiography (MCG) in patients with hypertrophic cardiomyopathy (HCM). The use of MCG has not been extensively studied in these patients.
- Trial name
- NCT00574821
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Hypertrophic Cardiomyopathy
Exercise Training in Patients With Hypertrophic Cardiomyopathy
Exercise training (ET) is highly beneficial in heart failure patients and has been suggested to confer significant symptomatic and functional improvements in patients with diastolic dysfunction.
- Trial name
- NCT01518114
- Testing
- Exercise Training
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Sheba Medical Center
Femoral Artery Injury, Aortic Valve Insufficiency
Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery
The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter…
- Trial name
- MANTA-MICS (NCT04802200)
- Testing
- Data collect
- Where
- France
- Volunteers
- 204 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Aortic Valve Stenosis, Aortic Valve Disease
CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation
This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, compared to educational control among patients recovering from transcatheter…
- Trial name
- NCT07008911
- Testing
- CardioHeartConnect, CardioHeartEd
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Colorado, Denver
Aortic Valve Stenosis
CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).
- Trial name
- NCT02209298
- Testing
- CoreValve Transcatheter Valve
- Where
- 25 sites in France, Germany and 2 more
- Volunteers
- 202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Mitral Regurgitation
Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Transcatheter mitral valve repair in the form of MitraClip® is a safe and effective alternative to surgical mitral valve repair/replacement in patients with high operative morbidity and mortality risk.
- Trial name
- NCT03993938
- Testing
- PVI measurement
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Henry Ford Health System
Endocarditis
Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism
Infective endocarditis (IE) is associated with an overall in-hospital mortality rate of 15-25% and a high incidence of embolic events (20-50%).
- Trial name
- CHIRURGENDO (NCT03718052)
- Testing
- Early valve surgery (EVS), Conventional Care
- Where
- France
- Volunteers
- 73 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Disease, Surgery--Complications
Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
There is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are…
- Conditions
- Aortic Valve Disease, Surgery--Complications, Immune System Disorder
- Trial name
- Measure (NCT04430972)
- Testing
- Aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Barts & The London NHS Trust
Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation
ECG and CXR for Predicting Cardiovascular Diseases
This retrospective multicenter cohort study aims to develop and validate an artificial intelligence model integrating electrocardiography (ECG) and chest radiography (CXR) to predict future progression of regurgitant valvular…
- Conditions
- Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation, Regurgitation, Aortic Valve, Regurgitation, Mitral
- Trial name
- NCT07573852
- Where
- China
- Volunteers
- 116,380 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Mitral Regurgitation, Computed Tomography
Atrial Fibrillation Risk After Miniinvasive Mitral Valve Repair
This retrospective cohort study investigates how CT-derived tissue quality parameters, serving as markers of metabolic status, predict post-operative atrial fibrillation risk in patients undergoing minimally invasive mitral valve…
- Conditions
- Mitral Regurgitation, Computed Tomography, Atrial Fibrillation
- Trial name
- NCT06707506
- Volunteers
- 114 people
- Sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
Aortic Stenosis, Aortic Valve Stenosis
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics)…
- Trial name
- NCT04827238
- Testing
- Standardized Invasive Hemodynamics
- Where
- 9 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- University of British Columbia
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
A virtual, self-directed, and tailored early mobilization program called JUMPSTART, that aims to bridge cardiac rehabilitation intake for post-TAVR patients has been developed at the Hamilton General Hospital.
- Trial name
- NCT06040398
- Testing
- JUMPSTART exercise program
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Hamilton Health Sciences Corporation
Aortic Valve Stenosis
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.
- Trial name
- NCT00986193
- Testing
- Transapical Aortic Valve Implantation, Conventional Aortic Valve Surgery
- Where
- Denmark
- Volunteers
- 72 people
- Sponsor
- Aarhus University Hospital Skejby
Cardiac Surgical Procedures, Coronary Artery Disease
Clinical Outcomes in Patients Treated With SternaLock Blu
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation.
- Conditions
- Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases
- Trial name
- SECURE (NCT03709693)
- Testing
- SternaLock Blu
- Where
- 4 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
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