Clinical trials: Pulmonary Regurgitation
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 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
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
Pulmonary Regurgitation
VenusP-Valve Pivotal Study (PROTEUS STUDY)
A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction.
- Trial name
- PROTEUS (NCT06010563)
- Testing
- Transcatheter pulmonary valve implantation (TPVI), VenusP-ValveTM System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation (TR)
Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)
The study is focused on evaluation of the effectiveness of the Admittance Pulmonary Artery Catheter (PAC) system for assessing the right ventricular (RV) function in patients with tricuspid regurgitation (TR) prior to tricuspid…
- Trial name
- NCT07500025
- Testing
- Right Heart Catheterization
- Volunteers
- 8 people
- Sponsor
- Feldman Cardiology, PLLC
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
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 Valve Insufficiency, Complex Congenital Heart Defect
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation
- Trial name
- NCT05378386
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Where
- 24 sites in United States, Israel
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Anesthesia, Gastric Ultrasound
Gastric Emptying Time in Traumatic Injuries
The investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) to estimate the gastric emptying time and dependant factors after traumatic injurys.
- Conditions
- Anesthesia, Gastric Ultrasound, Sonography, Point of Care Ultrasound (POCUS)
- Trial name
- NCT06643325
- Testing
- Gastric ultrasound
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- Kantonsspital Winterthur KSW
Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
- Trial name
- COMMENCE-P (NCT02656290)
- Testing
- Edwards Pericardial Aortic Bioprosthesis Model 11000A
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
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
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
Right Ventricular Outflow Tract Stenosis
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.
- Trial name
- NCT02071654
- Testing
- Venus P-valve transcatheter implantation
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
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
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
Tricuspid Regurgitation, Pulmonary Regurgitation
Berlin Registry of Right Heart Interventions
The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo.
- Trial name
- NCT04570163
- Testing
- Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany
Aortic Insufficiency, Aortic Stenosis
Automated Phonocardiography Analysis in Adults
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers…
- Conditions
- Aortic Insufficiency, Aortic Stenosis, Mitral Insufficiency, Mitral Insufficiency and Aortic Stenosis
- Trial name
- NCT03600051
- Testing
- Automated Heart Murmur Detection AI
- Where
- Austria
- Volunteers
- 90 people
- Sponsor
- CSD Labs GmbH
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
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