Clinical trials: Pulmonary Valve Regurgitation
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
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
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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.
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.
Mitral Valve Regurgitation, Pulmonary Hypertension
Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation
The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve…
- Trial name
- NCT03154034
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- University Hospital Regensburg
Pulmonary Hypertension, Mitral Regurgitation
Effect of Brief Nebulization of Milrinone on Pulmonary Arterial Pressure Before Cardiopulmonary Bypass on Mitral Valve Surgery Patients
Our main hypothesis is that inhalation of milrinone can reduce the elevated pulmonary arterial pressure due to severe mitral valve regurgitation without compromising systemic hemodynamics.
- Trial name
- NCT01621971
- Testing
- inhaled milrinone, intravenous milrinone
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Konkuk University Medical Center
Healthy Adults, Pulmonary Hypertension
A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology.
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure
- Trial name
- NCT07292896
- Where
- 25 sites in China
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- First Hospital of China Medical University
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease.
- Conditions
- Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF), Pulmonary Regurgitation, Sodium-glucose Cotransporter 2 (SGLT2) Inhibitor
- Trial name
- STEPS (NCT06668389)
- Testing
- SGLT2 inhibitor (Dapagliflozin 10mg)
- Where
- Hong Kong
- Volunteers
- 106 people
- Sponsor
- The University of Hong Kong
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
Tetralogy of Fallot, Pulmonary Valve Insufficiency
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood…
- Conditions
- Tetralogy of Fallot, Pulmonary Valve Insufficiency, Ventricular Dysfunction, Right
- Trial name
- NCT00112320
- Testing
- PVR plus RV remodeling, Standard PVR
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Boston Children's Hospital
Valvulopathy
Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction
Prospective Study, Single Arm to evaluate the safety and efficacy of polyurethane expandable valve implantation in the pulmonary position, in 5 patients over 18 years of age, with pulmonary valve dysfunction and moderate to…
- Trial name
- NCT05289622
- Testing
- Polyurethane expandable valve stent implant
- Where
- Brazil
- Volunteers
- 5 people
- Sponsor
- Dr. Miguel Angel Maluf
Pulmonary Regurgitation, Pulmonary Insufficiency
Pulmonic Valve REplacement Multi-discIpline EMEA Registry
The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery…
- Conditions
- Pulmonary Regurgitation, Pulmonary Insufficiency, Pulmonary Stenosis
- Trial name
- PREMIER (NCT01356108)
- Testing
- Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)
- Where
- 16 sites in Belgium, Germany and 7 more
- Volunteers
- 127 people
- Sponsor
- Edwards Lifesciences
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Severe Pulmonary Valve Regurgitation
Harmony TPV EMEA PMS
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as…
- Trial name
- NCT06906926
- Testing
- Certain imaging assessments can be non-Standard of Care
- Where
- 12 sites in Denmark, France and 6 more
- Volunteers
- 80 people
- Sponsor
- Medtronic Cardiovascular
Pulmonary Regurgitation, Congenital Heart Disease
Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease
The aim of the study is to assess the characteristics, incidence and predictors of load-independent right ventricle (RV) diastolic dysfunction in patients with congenital heart disease (CHD) and adverse RV loading conditions by…
- Trial name
- RaDICAL-CHD (NCT03471936)
- Testing
- Acquisition of pressure-volume-loops
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Heart Center Leipzig - University Hospital
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.
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
Cardiac Disease, Pulmonary Disease, Healthy Volunteer
Exploratory Study of the Diagnostic Potential of an Innovative Thoracic Vibration Analysis Technique
Heart and lung disease are two major causes of hospitalisation and mortality in France (4-8). Together, these two diseases affect several million people in France, either acutely or chronically.
- Conditions
- Cardiac Disease, Pulmonary Disease, Healthy Volunteer, Aortic Stenosis Disease, Mitral Regurgitation
- Trial name
- AIRFORCE2 (NCT06661200)
- Testing
- SMC signal recording
- Where
- France
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Heart Failure With Severe Tricuspid Regurgitation
TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure
Tricuspid regurgitation (TR) is a severe and highly prevalent disease that leads to right-sided heart failure. The severity of TR is associated with increasing morbidity and mortality.
- Trial name
- TRIC-I-HF 2 (NCT07442903)
- Testing
- Pulmonary artery sensor system
- Where
- 2 sites in Germany
- Volunteers
- 45 people
- Sponsor
- LMU Klinikum