Clinical trials: Valve Stenoses, Aortic
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
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
Aortic Valve Stenosis
Sentinel Low Risk Registry
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
- Trial name
- NCT04131127
- Testing
- Sentinel Device
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- CVPath Institute Inc.
Aortic Valve Stenosis, Coronary Artery Disease
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD.
- Trial name
- NCT04385459
- Testing
- Coronary artery disease
- Where
- Sweden
- Volunteers
- 346 people
- Sponsor
- Örebro County Council
Aortic Valve Stenosis
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
The purpose of this study is to investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification.
- Trial name
- NCT01939678
- Where
- Sweden
- Volunteers
- 3 people
- Sponsor
- Region Örebro County
Williams Syndrome
Response Inhibition Training for Children With Williams Syndrome
The investigators will conduct a pilot study investigating the effectiveness of a computerized response inhibition training program at reducing the response inhibition difficulties often seen in children with Williams syndrome…
- Trial name
- WSRIT (NCT02212314)
- Testing
- Response Inhibition Training
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Wisconsin, Milwaukee
Aortic Stenosis, Severe
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT04944667
- Testing
- TAVR planning
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Centro Medico Teknon
Cardiomyopathy, Hypertrophic, Heart Hypertrophy
Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM)
This study will examine the effectiveness of the drug cyclosporine in treating hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens.
- Trial name
- NCT00001965
- Testing
- Cyclosporine A
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Cardiomyopathy, Hypertrophic, Familial
Signs and Symptoms of Genetic Abnormalities Linked to Inherited Heart Disease
Genetically inherited heart diseases (familial cardiomyopathies) are conditions affecting the heart passed on to family members through abnormalities in genetic information.
- Trial name
- NCT00001881
- Where
- United States
- Volunteers
- 9,999 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
Alternative Peripheral TAVI Accesses
The APTA (Alternative Peripheral TAVI Accesses) registry is an observational multi-center, retrospective and prospective study, including high and medium - risk patients with aortic stenosis (AS) contraindicates for trans-femoral…
- Trial name
- APTA (NCT07539909)
- Testing
- TAVI procedures with an alternative access
- Volunteers
- 600 people
- Sponsor
- Medical University of Silesia
Aortic Valve Stenosis
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
- Trial name
- NCT03699345
- Testing
- Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 11 sites in Denmark, France and 4 more
- Volunteers
- 87 people
- Sponsor
- Edwards Lifesciences
Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic
Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy
This study will investigate whether there is an association between insulin resistance and cardiac function in children with dilated or hypertrophic cardiomyopathy.
- Conditions
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Insulin Resistance
- Trial name
- NCT04222101
- Testing
- Oral glucose tolerance test
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Le Bonheur Children's Hospital
Aortic Valve Stenosis, Structural Valve Deterioration
Single Perclose Escalation Technique for Vascular Closure in TAVR
This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end…
- Conditions
- Aortic Valve Stenosis, Structural Valve Deterioration, Structural Valve Degeneration
- Trial name
- NCT05836311
- Testing
- One Perclose Proglide Suture, Two Perclose Proglide Suture
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Cardiomyopathy, Hypertrophic
The Role of Heart Stiff and Weak Atrium on Exercise Capacity in Patients With Hypertrophic Cardiomyopathy
This study will examine how heart stiffness and a weak atrium affect exercise capacity and symptoms in patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT00074880
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Congenital Heart Disease, Aortic Valve Stenosis
Effect of Fetal Aortic Valvuloplasty on Outcomes
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects.
- Conditions
- Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
- Trial name
- FASSprosp (NCT05386173)
- Testing
- Fetal aortic balloon dilatation
- Where
- 13 sites in United States, Austria and 6 more
- Volunteers
- 200 people
- Sponsor
- Queen Silvia Children's Hospital, Gothenburg, Sweden
Velocardiofacial Syndrome, Williams Syndrome
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome
The purpose of this study is to investigate the Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to…
- Conditions
- Velocardiofacial Syndrome, Williams Syndrome, Fragile X Syndrome
- Trial name
- VCFS (NCT00768820)
- Testing
- methylphenidate, fluoxetin, risperidone
- Where
- Israel
- Volunteers
- 400 people
- Sponsor
- The Chaim Sheba Medical Center
Congenital Disorders
Children and Adolescents Receiving Mechanical and Prosthetic Valves
The primary objective of this retrospective study of valve replacement is to document long-term survival and occurrence of valve related complications such as described in the literature; anticoagulant related bleeding event …
- Trial name
- NCT00268008
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Children's Healthcare of Atlanta