Clinical trials: Pulmonary Valve Regurgitation
Congenital Heart Disease, Tetrology of Fallot
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of…
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT02979587
- Testing
- Harmony TPV System
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 86 people
- Sponsor
- Medtronic Heart Valves
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
Prospective Evaluation of AI-ECG for SHD Detection
AI-ECG-SHD is a multicentre prospective observational diagnostic accuracy study evaluating artificial intelligence-enhanced electrocardiography (AI-ECG) for the detection of structural heart disease in adults undergoing…
- Conditions
- Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis), Heart Failure With Reduced Ejection Fraction (HFrEF; Diagnosis), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
- Trial name
- AI-ECG-SHD (NCT07057466)
- Testing
- Traditional 12-lead Electrocardiogram, Apple Watch Series 4 Single-lead Electrocardiogram, Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram
- Where
- 6 sites in United Kingdom
- Volunteers
- 590 people
- Sponsor
- Imperial College London
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, Fallot Tetralogy
Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot
Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction.
- Conditions
- Congenital Heart Disease, Fallot Tetralogy, Ventricular Arrythmia, Pulmonary Valve Regurgitation
- Trial name
- NCT04205461
- Testing
- Programmed ventricular stimulation
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Paris Cardiovascular Research Center (Inserm U970)
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
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
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
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
Pulmonary Valve Insufficiency
Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract: a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical…
- Trial name
- NCT00259207
- Testing
- Pulmonary valve insertion, medical surgery hybride
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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