Clinical trials: Shunt Malfunction
Hydrocephalus, Ventriculoperitoneal Shunt Malfunction
Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies
Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults.
- Trial name
- NCT05534659
- Testing
- Programmable valve, Non-programmable valve
- Volunteers
- 325 people
- Sponsor
- Chang Gung Memorial Hospital
Heart Failure, Heart Failure, Diastolic
RESPONDER-HF Trial
Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization
- Trial name
- NCT05425459
- Testing
- Corvia Atrial Shunt System / IASD System II, Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
- Where
- 61 sites in United States, Australia and 5 more
- Volunteers
- 750 people
- Sponsor
- Corvia Medical
Hydrocephalus
Noninvasive Intracranial Pressure and Hydrocephalus Patients
Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (ICP) based on patients who have had traumatic brain injuries.
- Trial name
- NCT02404740
- Testing
- Pulse oximetry
- Volunteers
- 163 people
- Sponsor
- University of Colorado, Denver
Heart Failure, Heart Failure NYHA Class III
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms.
- Conditions
- Heart Failure, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction, Ambulatory Heart Failure, NYHA Class IV
- Trial name
- EASE HF2 (NCT06859970)
- Testing
- PAS-C System
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- InterShunt Technologies, Inc.
Cirrhosis
Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents
Coated stents with different diameters are presently commercially available, but clinical studies on the assessment of the best stent diameter for a better clinical efficacy, a reduced number of complications, and an effective…
- Trial name
- NCT00401895
- Testing
- TIPS created with 8 or 10 mm covered stent
- Where
- Italy
- Volunteers
- 44 people
- Sponsor
- University of Roma La Sapienza
Hydrocephalus
Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar
This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. The aim of this study is to evaluate the safety and efficacy of a modified ventriculoperitoneal catheter placement using a splitable…
- Trial name
- NCT05476874
- Testing
- Open Mini-Laparotomy, Abdominal Puncture
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Southern Medical University, China
COVID-19, Hypoxic Respiratory Failure
Almitrine and COVID-19 Related Hypoxemia
In severe COVID-19 pulmonary failure, the profound hypoxemia is mainly related to pulmonary vasodilation with altered hypoxic pulmonary vasoconstriction (HPV).
- Trial name
- NCT04380727
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Central Hospital, Nancy, France
Hepatic Encephalopathy
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy
A total of 40 patients taking proton pump inhibitors (PPIs) who undergo transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized in 1:1 fashion to either continue or…
- Trial name
- NCT05070351
- Testing
- PPI deprescribing
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Duke University
Cirrhosis, Liver, Hepatic Encephalopathy
Role of Sarcopenia and Nutritional/Physical Therapy Intervention in Post-TIPS Hepatic Encephalopathy
The placement of TIPS (transjugular intrahepatic portosystemic shunt) is the most effective strategy to treat complications of portal hypertension.
- Conditions
- Cirrhosis, Liver, Hepatic Encephalopathy, Sarcopenia
- Trial name
- NCT05346029
- Testing
- Lifestyle intervention
- Where
- 3 sites in Spain
- Volunteers
- 140 people
- Sponsor
- Anna Baiges
Pulmonary Arterial Hypertension
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible…
- Trial name
- RELIEVE-PAH (NCT03838445)
- Testing
- V-Wave Interatrial Shunt
- Where
- 3 sites in United States, Mexico
- Volunteers
- 9 people
- Sponsor
- V-Wave Ltd
Heart Failure
Alleviant ALLAY-HFrEF Study
Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in…
- Trial name
- NCT06812533
- Testing
- Alleviant ALV1 System
- Where
- 70 sites in United States, Australia and 9 more
- Volunteers
- 350 people
- Sponsor
- Alleviant Medical, Inc.
ESRD, Hemodialysis
Use of a Lifeline Graft in the A-V Shunt Model
This study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous fistula for dialysis access.
- Trial name
- NCT00850252
- Testing
- Lifeline
- Where
- 2 sites in Argentina, Poland
- Sponsor
- Cytograft Tissue Engineering
Hepatic Encephalopathy
Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation
Hepatic encephalopathy is a severe complication of transjugular intrahepatic portosystemic shunt (TIPS) treatment in patients with cirrhosis and variceal bleeding.
- Trial name
- DM-PTHE (NCT03372499)
- Testing
- diet management strategy for encephalopathy
- Where
- China
- Volunteers
- 86 people
- Sponsor
- Li Yang
Congestive Heart Failure
Atrial Flow Regulator in Heart Failure
The aim of the study is to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of Occlutech® Atrial flow regulator (AFR) device.
- Trial name
- PROLONGER (NCT04334694)
- Testing
- Atrial flow regulator (Occlutech® AFR device)
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Szpitale Pomorskie Sp. z o. o.
Heart Failure
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.
- Trial name
- EASE HF (NCT05403372)
- Testing
- PAS-C System
- Where
- Georgia
- Volunteers
- 10 people
- Sponsor
- InterShunt Technologies, Inc.
Heart Failure
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
- Trial name
- ALT-FLOW US (NCT03523416)
- Testing
- Edwards APTURE transcatheter shunt system
- Where
- 19 sites in United States
- Volunteers
- 90 people
- Sponsor
- Edwards Lifesciences
Kidney Failure, Chronic
Effect of Exercise on Endothelial Function and Vascular Compliance in Chronic Kidney Disease
The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial function and venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20…
- Trial name
- NCT01068314
- Testing
- Repetitive arm exercise
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Iowa
Liver Cirrhosis, Hepatic Encephalopathy
Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liver Cirrhosis
This study aims to develop a practical tool for identifying cirrhotic patients at high risk of hepatic encephalopathy following transjugular intrahepatic portosystemic shunt (TIPS) placement.
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy, TIPS
- Trial name
- NCT07437638
- Where
- China
- Volunteers
- 624 people
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
Hemodialysis Fistula Thrombosis
Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis
The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail.
- Trial name
- NCT00737620
- Testing
- Prosthetic AV graft implantation
- Where
- Israel
- Volunteers
- 160 people
- Sponsor
- Shaare Zedek Medical Center
End-stage Renal Disease
Propaten Randomized Investigation on Cost-benefit and Efficacy
The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.
- Trial name
- PRICE (NCT01601873)
- Testing
- PROPATEN, Standard Graft
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- The University of Texas Health Science Center, Houston