Clinical trials: Valve
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.
Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate.
- Trial name
- NCT01237743
- Testing
- Transcatheter aortic valve implantation.
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Sahlgrenska University Hospital
Coronary Artery Bypass Grafting, Surgical Treatment for Heart Valve Diseases
China Cardiovascular Surgery Registry
China Cardiovascular Surgery Registry (CCSR) Study is a national database for coronary artery bypass grafting (CABG) and valve surgery performed in 87 hospitals with cardiovascular surgery volume > 100 per year.
- Trial name
- CCSR (NCT02400125)
- Where
- China
- Volunteers
- 90,000 people
- Sponsor
- China National Center for Cardiovascular Diseases
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Para-prosthetic Heart
Para-Prosthetic Valve Leak Closure Observatory - PVLC2
Para-prosthetic heart valve leakage is an evolving complication after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.
- Trial name
- FFPP2 (NCT07049991)
- Testing
- surgical or percutaneous heart valve replacement.
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Ischemic Heart Disease, Valvular Heart Disease
Vigileo FloTrac vs Pulmonary Artery Catheter
To study the role of Vigileo monitor using the FloTrac sensor to measure cardiac output using the pulse contour analysis as well as central venous oxygen saturation monitoring as a guide for tissue perfusion.
- Trial name
- NCT00641290
- Testing
- Vigileo FloTrac Sensor
- Where
- Malaysia
- Volunteers
- 60 people
- Sponsor
- Hospital Sultanah Aminah Johor Bahru
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
Cardiovascular Diseases, Heart Diseases
Logical Analysis of Data and Cardiac Surgery Risk
To use a new statistical method, the Logical Analysis of Data (LAD), to predict cardiac surgery risk.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Aortic Valve Stenosis
- Trial name
- NCT00081666
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Primary Cardiomyopathy, Dilated Cardiomyopathy
Risk Stratification in Children and Adolescents With Primary Cardiomyopathy
RIKADA is a prospective study performing systematic family screening including clinical and genetic testing in pediatric patients with primary cardiomyopathy and their first-degree relatives with the aim to facilitate risk…
- Conditions
- Primary Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Left Ventricular Noncompaction
- Trial name
- RIKADA (NCT03572569)
- Where
- 2 sites in Germany
- Volunteers
- 200 people
- Sponsor
- German Heart Institute
Cardiac Valve Disease, Aortic Valve Stenosis
Remote ECG Monitoring of TAVI Patients
After surgery, patients who undergo transcatheter aortic valve implantation (TAVI) are at risk of developing cardiac arrhythmias such as heart blocks and atrial fibrillation.
- Trial name
- NCT03810820
- Testing
- mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
- Where
- Canada
- Volunteers
- 240 people
- Sponsor
- Population Health Research Institute
Cardiac Double Valve Replacement
Patient Outcome After Cardiac Double Valve Replacement at University Hospital Basel/ Switzerland
To compare patient outcome data after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction
- Trial name
- NCT03667274
- Testing
- cardiac valve surgery
- Where
- Switzerland
- Volunteers
- 106 people
- Sponsor
- University Hospital, Basel, Switzerland
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.
Primary Chronic Venous Insufficiency
The Clinical Trial for Primary Chronic Venous Insufficiency
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.
- Trial name
- NCT00931424
- Testing
- valve reconstruction
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Sun Yat-sen University
Hypertrophic Cardiomyopathy
Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy: A Pilot Study
This study will test the feasibility of a modified procedure for treating obstructive hypertrophic cardiomyopathy (OHC). Patients with OHC have a thickening of the heart muscle that obstructs blood flow out of the heart, causing…
- Trial name
- NCT00035386
- Testing
- trans-right ventricular alcohol septal ablation (TRVASA)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Pulmonary Valve Disorder, Congenital Heart Disease
INSPIRIS RESILIA Valve in Pulmonary Position
In this trial we intend to evaluate the safety and effectiveness of the INSPIRIS valve prothesis in the pulmonary position in patients of five years or older, with congenital or acquired pulmonary valve disease, requiring…
- Trial name
- NCT05583656
- Testing
- Pulmonary valve replacement
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Vienna
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
Bicuspid Aortic Valve (BAV)
A Study of Chinese Congenital Bicuspid Aortic Valve
Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV.
- Trial name
- NCT06802016
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Ruijin Hospital
Aortic Valve Disease
Outcomes of Surgery of Aortic Valve
Overall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as Ozaki's procedure and their subsequent…
- Trial name
- Aortic Surgery (NCT04277572)
- Testing
- Aortic valve replacement
- Volunteers
- 30 people
- Sponsor
- Assiut University
Tricuspid Regurgitation
TriClip Japan Post-Approval Study
The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following…
- Trial name
- TriClip JP PAS (NCT07509658)
- Testing
- The TriClip System
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Abbott Medical Devices