Clinical trials: Device Replacement
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Acute Kidney Injury
Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney injury (AKI).
- Trial name
- NCT01400893
- Testing
- SCD
- Where
- 26 sites in United States
- Volunteers
- 134 people
- Sponsor
- SeaStar Medical
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve…
- Conditions
- Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency
- Trial name
- NCT07363473
- Testing
- J-Valve Transfemoral System
- Volunteers
- 50 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Aortic Valve Stenosis
DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
- Trial name
- NCT02073851
- Testing
- TriGuard™HDH
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Keystone Heart
Heart Failure
BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure.
- Trial name
- NCT00929474
- Testing
- QuickOpt - SJM CRT (Group 1), Control - SJM CRT (Group 2)
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices
Sanfilippo Syndrome
Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of rhHNS Administration Via an IDDD in Pediatric Patients With Early Stage MPS IIIA Disease
Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase).
- Trial name
- NCT02060526
- Testing
- Recombinant human heparan N-sulfatase [rhHNS]
- Where
- 10 sites in United States, Argentina and 6 more
- Volunteers
- 21 people
- Sponsor
- Shire
Tricuspid Valve Regurgitation, Heart Valve Diseases
2019-06 TRISCEND Study
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT04221490
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 228 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
- Trial name
- NCT07205341
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- HemoCept Inc.
Total Knee Arthroplasty
NEUROCUPLE™ in TKA Patients to Enhance Pain Management
This is a randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE™ patch for pain reduction and opioid consumption following TKA.
- Trial name
- NCT06460350
- Testing
- NEUROCUPLE™ Patch
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- nCap Medical
Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device.
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- GUARDIAN (NCT06962371)
- Testing
- cerebral embolic protection
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Transverse Medical, Inc.
Opiate Addiction, Medication Non-adherence
Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy
This study uses an artificial intelligence platform to automatically confirm medication ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform can be downloaded as an 'app' onto any…
- Conditions
- Opiate Addiction, Medication Non-adherence, Addiction, Opioid Dependence
- Trial name
- NCT02243670
- Testing
- AiCure monitoring and intervention
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- AiCure
Transcatheter Aortic Valve Replacement (TAVR)
EasyCrossTM Device-Self-centering Catheter
VIVHEART EasyCross™ is a self-centering device for inserting a guidewire through a heart valve. It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms…
- Trial name
- VIV-FIH (NCT06412354)
- Testing
- EasyCross™ first-in human
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Vivheart s.r.l.
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Tricuspid Valve Regurgitation, Heart Valve Diseases
TRISCEND JAPAN Study
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe…
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRISCEND JAPAN (NCT05760989)
- Testing
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Where
- 8 sites in Japan
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical
Radial Head Fractures
A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint
The purpose of this study is to establish survivorship defined by the cumulative incidence of revision over the first 6 months post-implantation.
- Trial name
- NCT05415592
- Testing
- DePuy Synthes Radial Head Replacement System
- Where
- 4 sites in United States, United Kingdom
- Sponsor
- DePuy Synthes Products, Inc.
Hip Disease, Hip Fractures
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real…
- Trial name
- ESOP2 (NCT04193163)
- Testing
- Hip prosthesis - ESOP 2 cementless femoral stem
- Where
- 7 sites in France
- Volunteers
- 10 people
- Sponsor
- FH ORTHO
Venous Thromboembolism
Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System
Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or mechanical cardiac valve replacement, prevention or treatment…
- Trial name
- vMetrics-AMS (NCT00978445)
- Testing
- vMetrics protocol
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- ZIN Technologies, Inc.
Degenerative Disc Disease
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
- Trial name
- XL TDR (NCT00927238)
- Testing
- XL TDR, Lumbar fusion surgery
- Where
- 17 sites in United States
- Volunteers
- 246 people
- Sponsor
- NuVasive