Clinical trials: Device Replacement
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
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
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 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.
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
Smoking, Nicotine Addiction
The END Perioperative Smoking Pilot Study
The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes and telephone counselling (compared to transdermal nicotine replacement and telephone counselling) as a harm-reduction tool that may lead…
- Conditions
- Smoking, Nicotine Addiction, Surgery
- Trial name
- NCT02482233
- Testing
- ENDD (NJOY), NRT (NicoDerm CQ), telephone counseling
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of California, San Francisco
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.
Nicotine Addiction, Smoking Cessation
e-Cigarettes Versus NRT Gum for Smoking Cessation
This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt.
- Trial name
- NCT01925781
- Testing
- Nicotine polacrilex, STAM 1100mAh CE4 eGo Clearomizer
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Creighton University
Aortic Stenosis
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Background: Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement.
- Trial name
- NCT03432494
- Testing
- Transcaval closure device (TCD)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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
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
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.
Acute Renal Failure
Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure
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 renal failure (ARF).
- Trial name
- NCT01072682
- Testing
- Selective cytopheretic device (SCD)
- Where
- 7 sites in United States
- Volunteers
- 35 people
- Sponsor
- SeaStar Medical
Total Knee Replacement Surgery
Adductor Canal Catheter Effectiveness and Safety Study
PRIMARY OBJECTIVE: Compare the effect of usual care with an adductor canal catheter (ACC) containing ropivacaine to the effect of usual care without an ACC on the second-postoperative-day pain levels among patients undergoing…
- Trial name
- ACCESS (NCT04639128)
- Testing
- Adductor Canal Catheter
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- Kaiser Permanente
Aortic Stenosis, Brain Infarction
Neuroprotection in Patients Undergoing Aortic Valve Replacement
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
- Conditions
- Aortic Stenosis, Brain Infarction, Cerebrovascular Accident, Stroke
- Trial name
- NCT02389894
- Testing
- Embol-X Embolic Protection Device, CardioGard Cannula
- Where
- 18 sites in United States, Canada
- Volunteers
- 383 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Arterial Occlusion, Cardiovascular Diseases
Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Hematoma
- Trial name
- NCT05637970
- Testing
- Perclose, Statseal
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, Los Angeles
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.