Clinical trials: Valve Disease, Heart
Aortic Valve Stenosis
Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation
The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation…
- Trial name
- NCT02007967
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Michigan
Mitral Valve Insufficiency, Atrial Fibrillation
Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function.
- Conditions
- Mitral Valve Insufficiency, Atrial Fibrillation, Heart Failure
- Trial name
- NCT01172184
- Testing
- Cardiac catheterization
- Where
- Taiwan
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Kaohsiung Veterans General Hospital.
Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy
Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)
First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]).
- Trial name
- NCT02619825
- Testing
- Echography, Elastography
- Where
- France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- French Cardiology Society
Pulmonary Regurgitation, Tetralogy of Fallot
Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22…
- Trial name
- Venus-P (NCT02590679)
- Testing
- Venues-P Valve
- Where
- 3 sites in China
- Volunteers
- 44 people
- Sponsor
- Shanghai Zhongshan Hospital
Fragile X Syndrome, Williams Syndrome
Cooperative Parent Mediated Therapy in Children With Fragile X Syndrome and Williams Syndrome
Fragile X Syndrome (FXS) and Williams-Beuren Syndrome (WBS) are relatively rare disorders characterized by developmental delay associated to socio-communicative deficit and autistic-like behaviours.
- Trial name
- NCT04610424
- Testing
- Cooperative Parent Mediated Therapy" (CPMT), As usual
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
Aortic Valve Stenosis
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low…
- Trial name
- 3MTAVR (NCT02287662)
- Testing
- Vancouver 3M Clinical Pathway
- Where
- Canada
- Volunteers
- 411 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Right Ventricular Dysfunction
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction.
- Trial name
- TOF-Cond (NCT00557934)
- Testing
- dobutamine
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital Tuebingen
Mitral Regurgitation
The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation
Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation.
- Trial name
- PMA (NCT03038204)
- Testing
- The papillary muscle approximation
- Volunteers
- 100 people
- Sponsor
- The Federal Centre of Cardiovascular Surgery, Russia
Mitral Regurgitation, Mitral Valve Disease
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing…
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Stenosis
- Trial name
- NCT06167213
- Testing
- SAPIEN X4 THV
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Heart Valve Disease
European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where ESPOIR pulmonary valve (PV) is prescribed in the usual manner in…
- Trial name
- ESPOIR (NCT02035540)
- Testing
- Decellularized human valves
- Where
- 8 sites in Belgium, France and 6 more
- Volunteers
- 121 people
- Sponsor
- corlife
Bicuspid-related Aortopathy, Aortic Stenosis
PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)
Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery.
- Trial name
- PROSPERO-TAVI (NCT06248294)
- Testing
- CT follow-up
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University of Catania
Tetralogy of Fallot, Pulmonary Regurgitation
Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation
Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year.
- Trial name
- NCT04084132
- Testing
- Pulmonary valve replacement
- Where
- 3 sites in Denmark
- Volunteers
- 120 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Rheumatic Heart Disease in Children
School-based Program for the Prevention of Rheumatic Heart Disease in Endemic Regions
The overall objective of the PREVENT trial is to evaluate the effectiveness of an integrated, school-based program for the prevention of rheumatic heart disease (RHD) in regions with an endemic pattern of RHD.
- Trial name
- PREVENT (NCT06720272)
- Testing
- School nurse program
- Where
- 2 sites in Nepal, Zambia
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Thomas Pilgrim
Infective Endocarditis, Congenital Heart Disease
Infective Endocarditis in Percutaneous Pulmonary Revalvulation: Comparison Between Melody and Sapien Valves
Percutaneous pulmonary valve revalvulation (PPVR) has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction.
- Conditions
- Infective Endocarditis, Congenital Heart Disease, Percutaneous Pulmonary Valve Implantation
- Trial name
- Endopulm (NCT06186258)
- Testing
- percutaneous pulmonary valve implantation (PPVI)
- Where
- 18 sites in France, Germany and 5 more
- Volunteers
- 300 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Williams Syndrome
Clemastine Treatment in Individuals With Williams Syndrome
This study explores the neurobiological etiology of Williams syndrome and potential therapeutic targets for associated social, motor, and cognitive abnormalities.
- Trial name
- NCT06087757
- Testing
- Open Label Clemastine with a blinded randomize withdrawal
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Sheba Medical Center
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.
- Trial name
- NCT03417011
- Testing
- Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
- Where
- 39 sites in Austria, Belgium and 12 more
- Volunteers
- 638 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral…
- Trial name
- NCT02786264
- Testing
- Dexmedetomidine with propofol, Propofol
- Volunteers
- 186 people
- Sponsor
- Yale University
Tricuspid Atresia, Hypoplastic Left Heart Syndrome
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.
- Conditions
- Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Unbalanced AV Canal
- Trial name
- BHFSVP (NCT00571233)
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of California, San Francisco
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.