Clinical trials: Shunt Malfunction
Heart Failure
Alleviate-HF-2 Study
Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% < EF < 50%) with mild to moderate functional limitation will be evaluated…
- Trial name
- NCT04838353
- Testing
- ALV1 System
- Where
- 5 sites in Australia, Canada and 2 more
- Volunteers
- 13 people
- Sponsor
- Alleviant Medical, Inc.
Heart Failure
Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)
The Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE…
- Trial name
- NCT04000607
- Testing
- APTURE transcatheter shunt
- Where
- 2 sites in Canada
- Volunteers
- 45 people
- Sponsor
- Edwards Lifesciences
Congestive Heart Failure
The V-Wave Shunt: FIM Safety and Feasibility Study
The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF)…
- Trial name
- VW-SP-1 (NCT01965015)
- Testing
- Implantation of the V-Wave inter-atrial shunt
- Where
- 6 sites in Germany, Israel and 1 more
- Volunteers
- 16 people
- Sponsor
- V-Wave Ltd
Heart Failure
ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
- Trial name
- ALT-FLOW II (NCT05686317)
- Testing
- Edwards APTURE transcatheter shunt system
- Where
- 25 sites in United States, Brazil and 3 more
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Heart Failure
The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
- Trial name
- AFR Registry (NCT04405583)
- Testing
- Occlutech Atrial Flow Regulator
- Where
- 36 sites in France, Germany and 6 more
- Volunteers
- 150 people
- Sponsor
- Occlutech International AB
Congestive Heart Failure, Ascites
The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance.
- Trial name
- NCT00907673
- Testing
- Automatic Fluid Shunt System
- Where
- Sweden
- Volunteers
- 2 people
- Sponsor
- NovaShunt AG
Heart Failure
ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)
The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter…
- Trial name
- AlT-FloW (NCT04965623)
- Testing
- Atrial Shunt
- Sponsor
- Edwards Lifesciences
Heart Failure
Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System
The objectives of this early feasibility study are to: evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system for treatment of symptomatic HFrEF patients with elevated LAP, provide guidance…
- Trial name
- ALT-FLOW HFrEF (NCT07858799)
- Testing
- Edwards APTURE transcatheter shunt system
- Where
- 3 sites in Germany
- Volunteers
- 15 people
- Sponsor
- Edwards Lifesciences
Heart Failure
REDUCE LAP-HF III Corvia Protocol 1701
This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System…
- Trial name
- REDUCELAPHFIII (NCT03191656)
- Testing
- IASD Implant
- Where
- 27 sites in Germany, Switzerland
- Volunteers
- 500 people
- Sponsor
- Corvia Medical
Heart Failure
ALLEVIATE-HF-HD Study
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF 25-39%), or mid-range left ventricular ejection fraction (HFmrEF, EF 40-49%), or preserved left ventricular ejection fraction (HFpEF, EF ≥…
- Trial name
- NCT05501652
- Testing
- ALV1System
- Where
- Georgia
- Volunteers
- 5 people
- Sponsor
- Alleviant Medical, Inc.
Heart Failure
Reducing Lung CongestIon Symptoms in Advanced Heart Failure
The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association…
- Trial name
- RELIEVE-HF (NCT03499236)
- Testing
- V-Wave Interatrial Shunt, Control
- Where
- 83 sites in United States, Australia and 9 more
- Volunteers
- 605 people
- Sponsor
- V-Wave Ltd
Heart Failure
NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
A Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYA™ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd.
- Trial name
- NCT05375110
- Testing
- NoYA™ Radiofrequency Interatrial Shunt System
- Where
- 31 sites in China
- Volunteers
- 120 people
- Sponsor
- Hangzhou NOYA MedTech Co. Ltm.
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
ALLEVIATE-HFrEF Study
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using…
- Trial name
- NCT05133089
- Testing
- ALV1 System
- Where
- Georgia
- Volunteers
- 5 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
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
This study will evaluate the V-Wave Ventura Interatrial shunt. The Shunt is a small, hourglass-shaped device implanted in the dividing wall (septum) between the right and left atria (top chambers) of the heart placed during a…
- Conditions
- Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic, Heart Failure New York Heart Association Class III, Heart Failure Congestive
- Trial name
- RELIEVE-HFrEF (NCT07696975)
- Testing
- Implantation of the V-Wave Interatrial shunt
- Volunteers
- 250 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.
Heart Failure, Pulmonary Hypertension
Rivet PVS Therapy in Group 2 PH-HFpEF Canada
This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with…
- Trial name
- NCT05332873
- Testing
- Rivet Shunt
- Where
- Canada
- Sponsor
- NXT Biomedical
Heart Failure
Alleviant ALLAY-HF Study
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with…
- Trial name
- NCT05685303
- Testing
- Alleviant ALV1 System
- Where
- 93 sites in United States, Australia and 12 more
- Volunteers
- 700 people
- Sponsor
- Alleviant Medical, Inc.
Hydrocephalus
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH)…
- Trial name
- SCNPH (NCT01323764)
- Testing
- ShuntCheck test
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NeuroDx Development