Clinical trials: Device Replacement
Arthropathy of Hip
Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement
The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral…
- Trial name
- NCT01684631
- Testing
- Total Hip arthroplasty
- Where
- 6 sites in France
- Volunteers
- 107 people
- Sponsor
- DePuy International
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
COVID-19
Registry of CytoSorb Therapy in COVID-19 ICU Patients
The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
- Trial name
- CTC REGISTRY (NCT04391920)
- Testing
- CytoSorb 300 mL device
- Where
- 7 sites in United States
- Volunteers
- 138 people
- Sponsor
- CytoSorbents, Inc
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR LVAD Registry
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically…
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- JENA-VAD (NCT06594705)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- JenaValve Technology, Inc.
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
Mitral Valve Regurgitation (Degenerative or Functional)
Edwards EVOQUE Eos MISCEND Study
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
- Trial name
- NCT02718001
- Testing
- Edwards EVOQUE Eos Mitral Valve Replacement System
- Where
- 19 sites in United States, Canada
- Volunteers
- 123 people
- Sponsor
- Edwards Lifesciences
Aortic Arch; Aneurysm, Dissecting
Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta
The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation…
- Trial name
- NCT03735472
- Testing
- Thoraflex™ Hybrid
- Where
- 37 sites in France
- Volunteers
- 351 people
- Sponsor
- Vascutek Ltd.
Osteo Arthritis Knee, Knee Arthritis
Persona IQ Cohort Study
A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative…
- Conditions
- Osteo Arthritis Knee, Knee Arthritis, Monitoring Orthopedic Devices, Total Knee Arthroplasty
- Trial name
- NCT06089291
- Testing
- Persona IQ
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Tricuspid Valve Regurgitation, Heart Valve Diseases
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT06569602
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 23 sites in Germany, Greece and 4 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Psychological Stress, Cardiopulmonary Bypass Surgery
CARINAE for Stress Relief in Perioperative Care
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure.
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement
- Trial name
- CARINAE (NCT05184725)
- Testing
- SaMD CARINAE
- Where
- 5 sites in Italy, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- Adhera Health, Inc.
Aortic Aneurysm, Aortic Aneurysm and Dissection
A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases, Aneurysm of Aorta, Thoracic
- Trial name
- RAPID (NCT07078383)
- Testing
- Rapidlink
- Where
- 21 sites in United States, Austria and 3 more
- Volunteers
- 150 people
- Sponsor
- Vascutek Ltd.
Surgical Wound
A Post-Market Clinical Investigation on Mepilex Border Post-Op
This is a retrospective, observational (non-interventional), single-arm, single-centre, post-market clinical investigation designed to verify clinical performance and safety of Mepilex Border Post-Op when used according to…
- Trial name
- ARCTIS (NCT04994145)
- Where
- Belgium
- Volunteers
- 560 people
- Sponsor
- Molnlycke Health Care AB
Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
The ShortCut™ Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented…
- Trial name
- NCT04952909
- Testing
- ShortCut™
- Where
- 23 sites in United States, France and 3 more
- Volunteers
- 60 people
- Sponsor
- Pi-cardia
Mitral Leaflet Prolapse
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation.
- Trial name
- NCT01415947
- Testing
- V Chordal
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- Edwards Lifesciences
Total Hip Replacement
IPC-CALF Versus GEKO in Post-op Total Hip Patients
This study is designed to compare the effect of IPC on post-operative circulation in lower limbs with gekoTM device after total hip replacement procedure.
- Trial name
- NCT02425917
- Testing
- geko, IPC-Calf
- Sponsor
- Firstkind Ltd
Knee Disease
Study Conducted on Patients Operated With a FHK ASYMETRIQUE 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 FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when…
- Trial name
- NCT04221581
- Testing
- Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis
- Where
- 3 sites in France
- Volunteers
- 43 people
- Sponsor
- FH ORTHO
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.
Arthroplasty, Hip, Replacement
Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
- Trial name
- NCT05044767
- Testing
- total hip arthroplasty
- Where
- 13 sites in France
- Volunteers
- 4,500 people
- Sponsor
- ATF Implants
Knee Osteoarthritis, Osteoarthritis of the Knee
Postmarketing Multicenter Study of Intra-Articular DIART ONE / EASYGO ONE for Knee Osteoarthritis
This study looked at how safe and effective a hyaluronic acid-based injection (called DIART ONE or EASYGO ONE) is for people with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis, Osteoarthritis of the Knee, Degenerative Joint Disease
- Trial name
- NCT06927934
- Where
- Ukraine
- Volunteers
- 55 people
- Sponsor
- Yuria-Pharm
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart