Clinical trials: Right Ventricular Outflow Tract Dysfunction
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 Hypertension, Right Ventricular Outflow Tract Dysfunction
Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease
This study evaluates whether new flow parameters of the cardiac magnetic resonance imaging (MRI) allow evaluation of parameters for which usually invasive rigth-left heart catheterization are necessary.
- Conditions
- Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction, Fontan Circulation
- Trial name
- NCT07742046
- Testing
- Right-left heart catheterization in magnetic resonance imaging (MRI)
- Where
- Switzerland
- Volunteers
- 130 people
- Sponsor
- Tobias Rutz
Native Right Ventricle Outflow Tract(RVOT) Dysfunction
VenusP-Valve™ System Long-term Follow-up 6-10 Years
The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system…
- Trial name
- NCT07531303
- Volunteers
- 55 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Right Ventricular Outflow Tract Dysfunction
Observational Study of Venus P-Valve
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with…
- Trial name
- Registry (NCT05835349)
- Testing
- transcatheter pulmonary valve implantation (TPVI)
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 200 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Dysfunction of the Prosthetic Conduct, Lesions of the Right Ventricular Outflow Tract
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).
- Trial name
- REVALV (NCT01250327)
- Testing
- Melody, bare stent, Surgery
- Where
- France
- Volunteers
- 93 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Pulmonary Valve Malfunction, Right Ventricular Outflow Tract (RVOT) Dysfunction
Pulmonic SAPIEN S3™ THV Registry
Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up. The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN S3 transcatheter heart valve in the…
- Trial name
- PulmonicS3 (NCT02777892)
- Testing
- Sapien S3
- Where
- 4 sites in Canada, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Sinus-node Dysfunction
Right Ventricular Outflow Tract Study
This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path…
- Trial name
- RVOTCARE (NCT01294839)
- Testing
- Right ventricular lead location
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Abbott Medical Devices