Clinical trials: Complex Congenital Heart Defect, active
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
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
Congenital Heart Disease, Complex Congenital Heart Disease
A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease
The goal of this observational study is to learn about recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD), build a comprehensive data platform for CCHD care across a person's whole life, and…
- Conditions
- Congenital Heart Disease, Complex Congenital Heart Disease, Surgery (Cardiac), Perioperative Care
- Trial name
- NCT07524998
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- China National Center for Cardiovascular Diseases
Congenital Heart Disease (CHD), Eisenmenger Syndrome
Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome
The present study seeks to provide pilot data on the safety and efficacy of medical therapy with sotatercept in patients with an established diagnosis of congenital heart disease and Eisenmenger syndrome.
- Conditions
- Congenital Heart Disease (CHD), Eisenmenger Syndrome, PAH
- Trial name
- CHASE (NCT07498803)
- Testing
- Sotatercept
- Volunteers
- 40 people
- Sponsor
- Philipps University Marburg
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
Congenital Heart Disease (CHD), Complex Congenital Heart Disease
Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease
This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety.
- Conditions
- Congenital Heart Disease (CHD), Complex Congenital Heart Disease, Congenital Heart Disease in Children
- Trial name
- NCT06912412
- Testing
- Community-based supervised remote cardiac rehabilitation, Home-based cardiac rehabilitation program
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Seoul National University Hospital