Clinical trials: Pulmonary Valve Stenosis
Pulmonary Artery Stenosis, Aortic Coarctation
Minima Stent System Post- Approval Study (PAS)
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States.
- Trial name
- NCT06828770
- Testing
- Minima Stent System
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Renata Medical
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 Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
Tetrology of Fallot, Pulmonary Stenosis
MASA Valve Early Feasibility Study
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and…
- Conditions
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels
- Trial name
- MVEFS (NCT05452720)
- Testing
- Surgical Right Ventricular Outflow Tract Reconstruction
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- PECA Labs
Coarctation of the Aorta, Pulmonary Artery Stenosis
Growth Trial: Study of the Renata Minima Stent
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e.…
- Trial name
- NCT05086016
- Testing
- Catheterized Stenting
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Renata Medical
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.
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 Artery Stenosis
A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis
This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.
- Trial name
- IRIS (NCT04973540)
- Testing
- Iron Bioresorbable Scaffold System (IBS Angel)
- Where
- 10 sites in China
- Volunteers
- 82 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Trial name
- NCT03110861
- Testing
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Where
- 5 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Taewoong Medical Co., Ltd.
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
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.
Aortic Coarctation, Pulmonary Artery Stenosis
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions.
- Trial name
- Pediasorb (NCT07628101)
- Testing
- CardiaZn Bioresorbable Stent
- Volunteers
- 45 people
- Sponsor
- PediaStent LLC
Pulmonary Artery Stenosis
BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
- Trial name
- NCT03287024
- Testing
- BeGrow Stent System
- Where
- 3 sites in Austria, Serbia and 1 more
- Volunteers
- 18 people
- Sponsor
- Bentley InnoMed GmbH
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 Artery Stenosis
Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
The purpose of the clinical investigation is to characterize clinical outcomes and to assess the real-world use of the commercial PALMAZ MULLINS XD™ Pulmonary Stent.
- Trial name
- REALPASS (NCT07122518)
- Testing
- PALMAZ MULLINS XD™ Pulmonary Stent
- Where
- 8 sites in United States
- Volunteers
- 35 people
- Sponsor
- Cordis US Corp.
Pulmonary Regurgitation, Pulmonary Insufficiency
Pulmonic Valve REplacement Multi-discIpline EMEA Registry
The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery…
- Conditions
- Pulmonary Regurgitation, Pulmonary Insufficiency, Pulmonary Stenosis
- Trial name
- PREMIER (NCT01356108)
- Testing
- Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)
- Where
- 16 sites in Belgium, Germany and 7 more
- Volunteers
- 127 people
- Sponsor
- Edwards Lifesciences
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.