Clinical trials: Replacement
AKI - Acute Kidney Injury, Acute Renal Failure
A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
The goal of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease.
- Conditions
- AKI - Acute Kidney Injury, Acute Renal Failure, CKD, ESRD
- Trial name
- NCT05888376
- Testing
- Vascular access catheter to support dialysis or CRRT
- Where
- 2 sites in Poland
- Volunteers
- 76 people
- Sponsor
- Vantive Health LLC
Device Replacement, Elective Replacement (ERI)
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a…
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade
- Trial name
- REPLACE (NCT00395447)
- Testing
- Straight-forward Device Replacement, Device Replacement with Upgrade
- Where
- 71 sites in United States
- Volunteers
- 1,744 people
- Sponsor
- Biotronik, Inc.
Arthroplasty, Replacement, Knee
Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
- Trial name
- ANTHEM PS (NCT03078543)
- Testing
- ANTHEM™ PS Total Knee System implant
- Where
- 8 sites in China, Italy and 3 more
- Volunteers
- 148 people
- Sponsor
- Smith & Nephew, Inc.
Gaucher Disease
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003.
- Trial name
- NCT01422187
- Testing
- Taliglucerase alfa
- Volunteers
- 19 people
- Sponsor
- Pfizer
Arthroplasty, Replacement, Thromboembolism
Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery
An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE
- Trial name
- NCT00846807
- Where
- 112 sites in Austria, France and 7 more
- Volunteers
- 5,476 people
- Sponsor
- Boehringer Ingelheim
Transcatheter Aortic Valve Replacement
The CAPTIS® Study - Embolic Protection in TAVR
This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT04659538
- Testing
- CAPTIS Embolic Protection device
- Where
- 3 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Filterlex Medical Ltd.
Gaucher Disease
Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy.
- Trial name
- NCT00712348
- Testing
- Taliglucerase alfa
- Where
- 10 sites in United States, Australia and 4 more
- Volunteers
- 31 people
- Sponsor
- Pfizer
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Osteoarthritis, Knee, Arthritis, Rheumatoid
Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
The purpose of this study is to evaluate long-term clinical and radiographic data between geometrically identical GVF and cross-linked polyethylene-bearing inserts in total knee arthroplasty.
- Trial name
- NCT00289133
- Testing
- total knee arthroplasty
- Where
- 9 sites in United States
- Volunteers
- 938 people
- Sponsor
- DePuy Orthopaedics
Hypothyroidism
A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
The North Star study is a multi-center, Phase 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.
- Trial name
- NCT05712421
- Testing
- North Star, Levothyroxine
- Where
- 31 sites in United States
- Volunteers
- 303 people
- Sponsor
- Neuvosyn Laboratories, LLC
Open-angle Glaucoma, Ocular Hypertension
DuoTrav® Eye Drops As Replacement Therapy Program
To evaluate the effectiveness of DuoTrav Eye Drops in gaining or maintaining control of target Intraocular Pressures (tIOP) in patients diagnosed with, and being treated for, open-angle glaucoma (OAG) or ocular hypertension (OH).
- Trial name
- NCT00828906
- Testing
- DuoTrav
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Alcon Research
Symptomatic Aortic Stenosis
Optimize PRO Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and…
- Trial name
- NCT04091048
- Testing
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 1,127 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
TRISCEND II Pivotal Trial
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- NCT04482062
- Testing
- Edwards EVOQUE System, Optimal Medical Therapy
- Where
- 62 sites in United States, Germany
- Volunteers
- 864 people
- Sponsor
- Edwards Lifesciences
Pain, Postoperative
Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)
The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total knee replacement surgery.
- Trial name
- NCT00820027
- Testing
- Etoricoxib 90 mg, Etoricoxib 120 mg, Ibuprofen 600 mg
- Volunteers
- 776 people
- Sponsor
- Organon and Co
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
Mucopolysaccharidosis IVA, Morquio A Syndrome
Study of BMN 110 in Pediatric Patients < 5 Years of Age With Mucopolysaccharidosis IVA (Morquio A Syndrome)
This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of administration of the first dose of study drug…
- Conditions
- Mucopolysaccharidosis IVA, Morquio A Syndrome, MPS IVA
- Trial name
- NCT01515956
- Testing
- BMN 110
- Where
- 5 sites in United States, Italy and 2 more
- Volunteers
- 15 people
- Sponsor
- BioMarin Pharmaceutical
Gaucher Disease
An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112
This is an open-label, dose escalation study to evaluate the safety of oral PRX-112 and pharmacokinetics of GCD in subjects with Gaucher disease naive to enzyme replacement therapy.
- Trial name
- NCT02107846
- Testing
- PRX-112
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Protalix
Mucopolysaccharidosis Type IIIB, MPS IIIB (Sanfilippo B Syndrome)
Early Access Treatment With Tralesinidase Alfa in Mucopolysaccharidosis Type IIIB (Sanfilippo Syndrome Type B)
This is an intermediate-size patient population Early Access Program (EAP) providing access to intracerebroventricular (ICV) tralesinidase alfa (TA) for participants with mucopolysaccharidosis type IIIB (MPS IIIB, Sanfilippo…
- Trial name
- EAP (NCT07733856)
- Testing
- Tralesinidase alfa (TA)
- Where
- United States
- Sponsor
- Spruce Biosciences
Hormone Replacement Therapy
Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily…
- Trial name
- NCT01070979
- Testing
- Estradiol acetate, Estradiol, Conjugated equine estrogens
- Where
- 32 sites in United States
- Volunteers
- 249 people
- Sponsor
- Warner Chilcott
Heart Failure
Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair
The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac Support Device (CSD) placed around their heart for the treatment of heart failure at the same time as their mitral valve surgery.
- Trial name
- MVR + CorCap (NCT00630266)
- Testing
- CorCap CSD
- Where
- 12 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Acorn Cardiovascular, Inc.