Clinical trials: Pulmonary Valve Insufficiency
Tetralogy of Fallot
Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot
Summary: The investigators aim to identify markers of right ventricular dysfunction in patients with severe pulmonary regurgitation following repair of Tetralogy of Fallot, that allow prediction of the optimal timing of the…
- Trial name
- NCT00564993
- Testing
- Dobutamin
- Where
- 11 sites in Germany
- Volunteers
- 53 people
- Sponsor
- Competence Network for Congenital Heart Defects
Mitral Insufficiency, Pulmonary Arterial Hypertension
Surgical Valvuloplasty for Congenital Mitral Insufficiency
Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly.
- Trial name
- NCT03567668
- Testing
- mitral valvuloplasty
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hong Liu
Mitral Regurgitation, Pulmonary Hypertension
The Right Ventricular Pulmonary Circulation Continuum in Mitral Valve Disease Study
Mitral regurgitation (MR) is a prevalent valvular heart pathology. Indications for surgery include symptoms, impaired left ventricular function or enlarging dimensions, new onset atrial fibrillation, pulmonary hypertension…
- Trial name
- RIPCOM1 (NCT03155373)
- Testing
- Cardiac catheterisation, Cardiopulmonary exercise testing, Pulmonary function tests
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Imperial College London
Pulmonary Regurgitation After Repair of Tetralogy of Fallot
Tetralogy of Fallot Seed Grant
Patients with pulmonary regurgitation after surgical correction of ToF over 13 years old will be recruited from the UCSF adult congenital heart disease clinic.
- Trial name
- NCT00722826
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- University of California, San Francisco
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
Endomyocardial Fibrosis, Pulmonary Valve Stenosis
Right Ventricle Remodeling After Pulmonary Valve Replacement and Percutaneous Pulmonary Valve Insertion
This study investigates damage of the right cardiac chamber in adult patients with a congenital heart defect involving the pulmonary valve (the heart valve between the right cardiac chamber and the lungs).
- Conditions
- Endomyocardial Fibrosis, Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency
- Trial name
- RV-REPAIR (NCT05090228)
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- UMC Utrecht
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.
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 Reduced Ejection Fraction, Mitral Regurgitation
The CardioClip Study
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin.
- Trial name
- CardioClip (NCT06241430)
- Testing
- CardioMEMS
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Congenital Heart Disease, Tetrology of Fallot
Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT05077774
- Testing
- Harmony TPV System
- Where
- 20 sites in United States, Canada
- Volunteers
- 174 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
Pulmonary Valve Insufficiency
Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
- Trial name
- GECT (NCT05809856)
- Testing
- GrOwnValve - novel heart valve replacement approach
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Charite University, Berlin, Germany
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 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
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
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
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
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.
Coronary Artery Disease., Aortic Valve Stenosis.
Cerebral Oxymetry at Elective Coronary and Valve Surgery.
Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.
- Conditions
- Coronary Artery Disease., Aortic Valve Stenosis., Aortic Valve Regurgitation.
- Trial name
- Co-HLM (NCT01940874)
- Where
- Norway
- Volunteers
- 54 people
- Sponsor
- Oslo University Hospital
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.