Clinical trials: Shunt Malfunction
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
Chronic Heart Failure
Heart Failure (HF) Interatrial Shunt Study 1
The objective of this study, is to assess the safety and performance of an interatrial shunt when implanted in patients with severe chronic heart failure.
- Trial name
- NCT02511912
- Testing
- V-Wave
- Where
- Israel
- Sponsor
- V-Wave Ltd
Suspected CSF Shunt Obstruction
ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects…
- Trial name
- NCT01881711
- Testing
- ShuntCheck-Micro-Pumper (SCMP), Imaging
- Where
- 11 sites in United States
- Volunteers
- 400 people
- Sponsor
- NeuroDx Development
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.
Heart Failure
Alleviate-HF-1 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
- NCT04583527
- Testing
- ALV1 System
- Where
- Georgia
- Volunteers
- 15 people
- Sponsor
- Alleviant Medical, Inc.
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, Pulmonary Hypertension
Rivet PVS Therapy in Group 2 PH-HFpEF
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
- NCT05205265
- Testing
- Rivet Shunt
- Where
- 3 sites in United States
- Sponsor
- NXT Biomedical
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