Clinical trials: Class IV Angina
Heart Failure, Heart Failure, Systolic
Hemodynamic-GUIDEd Management of Heart Failure
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for…
- Conditions
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure NYHA Class II
- Trial name
- GUIDE-HF (NCT03387813)
- Testing
- CardioMEMS™ HF System
- Where
- 129 sites in United States, Canada
- Volunteers
- 2,358 people
- Sponsor
- Abbott Medical Devices
NYHA Class III Heart Failure, NYHA Class IV Heart Failure
Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C
The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.
- Trial name
- FIX-HF-5C (NCT01381172)
- Testing
- Optimizer System, No intervention: Optimal medical therapy
- Where
- 42 sites in United States, Czechia and 1 more
- Volunteers
- 160 people
- Sponsor
- Impulse Dynamics
Heart Failure
C-Pulse® System European Multicenter Study
The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.
- Trial name
- OPTIONS-HF (NCT01872949)
- Where
- 8 sites in Austria, Germany
- Volunteers
- 15 people
- Sponsor
- Nuwellis, Inc.
Lupus Nephritis
A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis
This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF…
- Trial name
- LUNAR (NCT00282347)
- Testing
- Rituximab, Mycophenolate mofetil, Methylprednisolone
- Volunteers
- 144 people
- Sponsor
- Genentech, Inc.
Heart Failure, Left Bundle-Branch Block
Mid-Q Response Study
The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study.
- Conditions
- Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure NYHA Class II
- Trial name
- NCT04180696
- Testing
- aCRT ON, aCRT OFF
- Where
- 61 sites in Brunei, China and 8 more
- Volunteers
- 177 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
C-Pulse IDE Feasibility Study- A Heart Assist System
The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better…
- Trial name
- NCT00815880
- Testing
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Nuwellis, Inc.
Class IV Angina
The PEARL 8.0 Post-Approval Study
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less…
- Trial name
- NCT01845103
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Class IV Angina
Cardiogenesis Transmyocardial Revascularization Registry
The objectives of the registry are as follows: Track "real world" performance outcomes and physician experience using the Cardiogenesis Laser System; Further define the disease characteristics of the population being treated…
- Trial name
- ANGINA RELIEF (NCT01827319)
- Where
- 24 sites in United States
- Volunteers
- 203 people
- Sponsor
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.