Clinical trials: Defects
Heart Failure, Transplant; Failure, Heart
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist…
- Conditions
- Heart Failure, Transplant; Failure, Heart, Congenital Heart Disease
- Trial name
- NCT05610787
- Testing
- EXCOR Active Driving System for Pediatric VAD
- Where
- 17 sites in United States
- Volunteers
- 40 people
- Sponsor
- Berlin Heart, Inc
Congenital Heart Disease, Congenital Heart Disease (CHD)
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System.
- Trial name
- NCT07114718
- Testing
- Ductus Arteriosus Stent
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Starlight Cardiovascular Inc
Knee Cartilage Defects
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
This study will test whether CARTISTEM is safe and works better than debridement (a surgery that cleans out damaged tissue) for people with knee cartilage damage and osteoarthritis.
- Trial name
- CARTISTEM23-01 (NCT07339111)
- Testing
- CARTISTEM® + Debridement, Debridement
- Where
- 35 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medipost, Inc.
Chondral Defect, Articular Cartilage Defect
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with…
- Trial name
- MASCOT (NCT06915233)
- Testing
- autologous cultured chondrocytes on porcine collagen membrane, Bone Marrow Stimulation
- Where
- 9 sites in United States
- Volunteers
- 309 people
- Sponsor
- Vericel Corporation
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Persistent Corneal Epithelial Defect
A Study to Evaluate the Efficacy and Safety of TP-06 for PCED
Capellion is a Phase 2 trial comparing TP-06 2.0% with Vehicle in up to 32 adults with persistent corneal epithelial defects. Participants will receive treatment for 8 weeks and be followed for 2 additional weeks to assess…
- Trial name
- Capellion (NCT07886268)
- Testing
- TP-06, Vehicle of TP-06
- Where
- 14 sites in United States, Dominican Republic and 2 more
- Volunteers
- 32 people
- Sponsor
- Tarsus Pharmaceuticals, 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
Congenital Heart Disease
Autus Valve Pivotal Study
Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT05006404
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- 12 sites in United States
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Congenital Heart Disease
Autus Valve Continued Access Study (CAS)
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT07466745
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology.
- Trial name
- NCT07884318
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Heart Diseases, Heart Failure
Global Utilization And Registry Database for Improved heArt preservatioN
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System.
- Conditions
- Heart Diseases, Heart Failure, Heart Defects, Congenital
- Trial name
- GUARDIAN (NCT04141605)
- Testing
- SherpaPak Cardiac Transport System
- Where
- 22 sites in United States, Austria and 2 more
- Volunteers
- 4,000 people
- Sponsor
- Paragonix Technologies
Chondral Defect, Osteochondritis Dissecans (OCD)
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the…
- Conditions
- Chondral Defect, Osteochondritis Dissecans (OCD), Articular Cartilage Defect, Articular Cartilage Disorder of Knee
- Trial name
- PEAK (NCT03588975)
- Testing
- MACI, microfracture
- Where
- 14 sites in United States
- Volunteers
- 45 people
- Sponsor
- Vericel Corporation
Atrial Septal Defect
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
- Trial name
- NCT05887700
- Testing
- CeraFlex™ Atrial Septal Defect (ASD) Closure System
- Where
- 10 sites in Brazil, Greece and 1 more
- Volunteers
- 145 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Craniofacial Defects
Long-term Safety and Performance of CMF Porous Titanium Implants
The goal of this retrospective study is to evaluate the clinical characteristics, efficiency, safety, and long-term performance of craniomaxillofacial (CMF) Porous Titanium Implants within the standard of care across children (0…
- Trial name
- CMF SafeTi Fit (NCT06910033)
- Testing
- Craniomaxillofacial (CMF) porous titanium implant
- Where
- 2 sites in Denmark, France
- Volunteers
- 200 people
- Sponsor
- Materialise
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Congenital Heart Disease, Advanced Heart Failure
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
TORCH-LATAM-003 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for children and adults with congenital heart disease and advanced cardiac and/or respiratory failure who may require heart…
- Conditions
- Congenital Heart Disease, Advanced Heart Failure, Respiratory Failure, Heart Transplantation
- Trial name
- TORCH-003 (NCT07837024)
- Testing
- TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Abdominal Wall Defect, Abdominal Wall Injury
Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma…
- Conditions
- Abdominal Wall Defect, Abdominal Wall Injury, Abdominal Hernia
- Trial name
- PMCF_AWR (NCT04580511)
- Testing
- CELLIS (Porcine Acellular Dermal Matrix, PADM)
- Where
- 4 sites in France
- Volunteers
- 92 people
- Sponsor
- Meccellis Biotech
Persistent Corneal Epithelial Defect
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
This is a phase 3, randomized, multicenter, double-masked, parallel group, vehicle-controlled prospective clinical trial to evaluate the safety and efficacy of cenegermin in inducing complete epithelial healing in participants…
- Trial name
- NCT07519902
- Testing
- Cenegermin, Vehicle
- Where
- 77 sites in United States, Argentina and 12 more
- Volunteers
- 150 people
- Sponsor
- Dompé Farmaceutici S.p.A
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