Clinical trials: Pulmonary Valve; Obstruction
Peripheral Artery Disease, Coronary Disease
Evaluation of Patients With Known or Suspected Heart Disease
In this study researchers will admit and evaluate patients with known or suspected heart disease referred to the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI).
- Conditions
- Peripheral Artery Disease, Coronary Disease, Diabetes and Heart Failure, Dilated Cardiomyopathy
- Trial name
- NCT00001313
- Where
- 2 sites in United States
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Tetrology of Fallot, Pulmonary Stenosis
MASA Valve Early Feasibility Study
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and…
- Conditions
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels
- Trial name
- MVEFS (NCT05452720)
- Testing
- Surgical Right Ventricular Outflow Tract Reconstruction
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- PECA Labs
Congenital Heart Disease
Retrospective Pulmonary Valve Replacement Imaging
This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement.
- Trial name
- NCT00446108
- Where
- 2 sites in United States
- Volunteers
- 153 people
- Sponsor
- Emory University
Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Trial name
- NCT03110861
- Testing
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Where
- 5 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Taewoong Medical Co., Ltd.
Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
- Conditions
- Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency
- Trial name
- SGPV (NCT01092442)
- Testing
- Echocardiogram
- Where
- 8 sites in United States
- Volunteers
- 140 people
- Sponsor
- CryoLife, Inc.
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
Congenital Heart Disease, Coarctation of Aorta
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative…
- Conditions
- Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis, Pulmonary Atresia
- Trial name
- NCT06768008
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Beijing Anzhen Hospital
Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery.
- Conditions
- Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return, Truncus Arteriosus, Pulmonary Atresia With Ventricular Septal Defect
- Trial name
- T-NOX (NCT04452188)
- Testing
- Normoxia (with controlled re-oxygenation), Standard of care ventilation
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Pulmonary Stenosis, Pulmonary Regurgitation
Pulmonary Artery Repair With Covered Stents
The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the right ventricle of the heart to the pulmonary…
- Conditions
- Pulmonary Stenosis, Pulmonary Regurgitation, Tetralogy of Fallot
- Trial name
- PARCS (NCT01824160)
- Testing
- Repair of RV-PA Conduit Disruption
- Where
- 38 sites in United States
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins University
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Kidney Transplant, Familial Hypercholesterolaemia
Cardiovascular Risk in Children With Chronic Conditions Study
Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels.
- Conditions
- Kidney Transplant, Familial Hypercholesterolaemia, Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM)
- Trial name
- CR3C (NCT07086989)
- Where
- 3 sites in Hungary
- Volunteers
- 300 people
- Sponsor
- Semmelweis University
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
Cardiovascular Diseases, Heart Diseases
Reproduction and Survival After Cardiac Defect Repair
To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart, Aortic Valve Stenosis
- Trial name
- NCT00005190
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Heart Diseases, Pulmonary Valve Regurgitation
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require…
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Trial name
- NCT03983512
- Testing
- PULSTA TPV System
- Where
- 11 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- Taewoong Medical Co., Ltd.
Aortic Stenosis, Mitral Regurgitation
Evaluating Infrasonic Hemodynography
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic
- Trial name
- NCT04636892
- Testing
- MindMics earbud
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Scripps Health
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
Congenital Heart Defects, Cardiovascular Abnormalities
A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)
The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.
- Conditions
- Congenital Heart Defects, Cardiovascular Abnormalities, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT02555319
- Testing
- Transcatheter Pulmonary Valve (TPV)
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Seoul National University Hospital
Congenital Disorders
Mild Valvar Pulmonary Stenosis
Mild valvar pulmonary stenosis can be detected in 1/10,000 live births. Historical data suggested that most of these patients do well.
- Trial name
- NCT00277927
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Children's Healthcare of Atlanta
Heart Disease
PULSTA TPV Observational Study
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
- Trial name
- NCT07747207
- Where
- 9 sites in Germany, Italy and 4 more
- Volunteers
- 200 people
- Sponsor
- Taewoong Medical Co., Ltd.