Clinical trials: Replacement
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475267
- Testing
- Trifecta aortic heart valve
- Where
- 5 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott Medical Devices
Hypogonadism, Cardiovascular Diseases
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.
- Trial name
- TRAVERSE (NCT03518034)
- Testing
- AndroGel®
- Where
- 384 sites in United States, Puerto Rico
- Volunteers
- 5,246 people
- Sponsor
- AbbVie
Neuromuscular Blockade, Arthroplasty, Replacement, Hip
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on…
- Conditions
- Neuromuscular Blockade, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Blood Coagulation
- Trial name
- NCT01422304
- Testing
- Sugammadex, neostigmine and glycopyrrolate or atropine
- Volunteers
- 1,198 people
- Sponsor
- Merck Sharp & Dohme LLC
Sly Syndrome, MPS VII
Study of UX003 Recombinant Human Beta-Glucuronidase (rhGUS) Enzyme Replacement Treatment in Mucopolysaccharidosis Type 7, Sly Syndrome (MPS 7) Patients Less Than 5 Years of Age
The primary objective was to evaluate the effect of UX003 treatment in pediatric MPS VII participants less than 5 years of age on safety, tolerability, and efficacy as determined by the reduction of urinary glycosaminoglycans…
- Conditions
- Sly Syndrome, MPS VII, Mucopolysaccharidosis, Mucopolysaccharidosis VII
- Trial name
- NCT02418455
- Testing
- UX003
- Where
- 5 sites in United States, Portugal and 1 more
- Volunteers
- 8 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Thromboembolism, Arthroplasty, Replacement, Hip
Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery
Open, prospective, uncontrolled, observational cohort study.
- Trial name
- NCT00967447
- Where
- 28 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Severe Pulmonary Valve Regurgitation
Harmony TPV EMEA PMS
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as…
- Trial name
- NCT06906926
- Testing
- Certain imaging assessments can be non-Standard of Care
- Where
- 12 sites in Denmark, France and 6 more
- Volunteers
- 80 people
- Sponsor
- Medtronic Cardiovascular
Gaucher Disease, Type 3
An Efficacy and Safety Study of AVR-RD-02 Compared to Enzyme Replacement Therapy for Treatment of Gaucher Disease Type 3
The purpose of this study is to evaluate the efficacy and safety of autologous hemotopoietic stem cell (HSC) gene therapy, AVR-RD-02, compared to enzyme replacement therapy, for the treatment of Gaucher disease Type 3 in male and…
- Trial name
- NCT05815004
- Testing
- Gene therapy, Enzyme Replacement Agent
- Sponsor
- AVROBIO
Knee Osteoarthritis
Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray
The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a cobalt chrome tibial tray at 5 years.
- Trial name
- NCT00734019
- Testing
- P.F.C. Sigma Knee
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 650 people
- Sponsor
- DePuy International
Mitral Regurgitation
Sutra Hemi-valve First-in-Human Study
Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for…
- Trial name
- NCT06552689
- Testing
- Sutra Hemi-valve Transcatheter Mitral Valve Replacement (TMVR) System
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- Sutra Medical, Inc.
Osteoarthritis of the Knee
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.
- Trial name
- NCT01820650
- Testing
- iTotal G2 CR Knee Replacement System
- Where
- 9 sites in United States
- Volunteers
- 359 people
- Sponsor
- Restor3D
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
Fabry Disease
Evaluate the Safety and Exploratory Efficacy of GC1119
The purpose of this study is to evaluate the safety and exploratory efficacy of GC1119 (recombinant human α-galactosidase A) for enzyme replacement therapy in Fabry disease patients.
- Trial name
- NCT01653444
- Testing
- GC1119
- Where
- 3 sites in South Korea
- Volunteers
- 8 people
- Sponsor
- Green Cross Corporation
Hemophilia B
Lead-in Study of VGB-R04 Gene Therapy for Hemophilia B-- An Observational Survey Analysis Study
This is a prospective, open, multicenter, observational lead-in study，to collect prospective efficacy and safety data of current replacement therapy in adult hemophilia B patients.
- Trial name
- NCT05442528
- Volunteers
- 20 people
- Sponsor
- Shanghai Vitalgen BioPharma Co., Ltd.
Post-surgical Pain
Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
The objectives of this study are to evaluate the safety and analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in patients undergoing unilateral total knee arthroplasty.
- Trial name
- NCT02807428
- Testing
- AYX1 Injection 660 mg/6 mL
- Where
- 9 sites in United States
- Volunteers
- 210 people
- Sponsor
- Adynxx, Inc.
Arthroplasty, Replacement, Hip
A Post Market Clinical Follow-up Study With the aneXys Cup
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.
- Trial name
- NCT03274830
- Testing
- aneXys
- Where
- 3 sites in Germany
- Volunteers
- 102 people
- Sponsor
- Mathys Ltd Bettlach
Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
- Trial name
- NCT01110967
- Where
- 3 sites in Czechia, Slovakia and 1 more
- Volunteers
- 40 people
- Sponsor
- Medtronic Spinal and Biologics
Rheumatoid Arthritis, Osteoarthritis
A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- Trial name
- NCT00208429
- Testing
- Pinnacle Acetabular System
- Sponsor
- DePuy International
Mitral Valve Regurgitation
Mitral Valve Replacement With MValve Dock and Lotus
This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.
- Trial name
- DOCK 1 (NCT02719912)
- Testing
- mitral valve replacement
- Where
- 4 sites in Brazil, France and 2 more
- Volunteers
- 30 people
- Sponsor
- MValve Technologies Ltd
Impulse Control Disorder
Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa
The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist to levodopa/carbidopa in patients with…
- Trial name
- REIN-PD (NCT01683253)
- Testing
- Levodopa/Carbidopa(200mg/50mg), Dopaminergic Agonists
- Where
- 5 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- Sandoz
Total Aortic Arch Replacement
Near-Infrared Spectroscopy Comparison Study
The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS…
- Trial name
- NCT01352260
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Nonin Medical, Inc