Clinical trials: Ventricular Failure
Heart Failure
Identifying and Facilitating Ventricular Recovery on Mechanical Support
Heart failure is a progressive disorder in which the weakened heart is not able to efficiently pump blood throughout the body. When the body's cells do not receive enough blood, this can result in fatigue, shortness of breath…
- Trial name
- RECOVER (NCT00687856)
- Testing
- Echocardiogram (echo)
- Where
- 5 sites in United States
- Volunteers
- 211 people
- Sponsor
- University of Pittsburgh
Heart Failure
Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)
After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile and could provide an…
- Trial name
- VAFRACT (NCT03937570)
- Testing
- echo-optimization
- Where
- Italy
- Volunteers
- 27 people
- Sponsor
- Universita di Verona
Chronic Heart Failure
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- ADVANCE (NCT00751972)
- Testing
- HeartWare® VAS
- Where
- 35 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Kidney Disease (CKD) Stage 5, Hypertrophy, Left Ventricular
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).
- Trial name
- PRIMO II (NCT00616902)
- Testing
- paricalcitol injection 4 mcg/mL
- Where
- 76 sites in United States, Australia and 11 more
- Volunteers
- 12 people
- Sponsor
- Abbott
Ischemic Cardiomyopathy
Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure
This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination…
- Trial name
- CONCERT-HF (NCT02501811)
- Testing
- Mesenchymal Stem Cells (MSC), c-kit+ cells
- Where
- 7 sites in United States
- Volunteers
- 125 people
- Sponsor
- The University of Texas Health Science Center, Houston
Heart Disease
Managed Ventricular Pacing ("MVP") Trial
The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and…
- Trial name
- MVP (NCT00281099)
- Testing
- ICD (Implantable Cardioverter Defibrillator)
- Where
- 73 sites in United States, Austria and 10 more
- Volunteers
- 1,031 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disorder, Aortic Valve Insufficiency
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
- Conditions
- Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure
- Trial name
- NCT01651052
- Testing
- Heart Valve Surgery
- Where
- 2 sites in Poland
- Volunteers
- 133 people
- Sponsor
- Edwards Lifesciences
Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
- Conditions
- Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction
- Trial name
- NCT03624010
- Testing
- Levosimendan
- Where
- 9 sites in United States
- Volunteers
- 35 people
- Sponsor
- Tenax Therapeutics, Inc.
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Systolic Heart Failure
Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
Medamacs is a prospective, observational study of ambulatory patients with advanced heart failure. The study enrolls patients who have not yet received a Left Ventricular Assist Device (LVAD) but who receive their care at a…
- Trial name
- Medamacs (NCT01932294)
- Where
- 11 sites in United States
- Volunteers
- 171 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Chronic Heart Failure, Patients That Have Received a Left Ventricular Assist Device
Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure
The aim of the study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the CMV promoter (AAV1-CMV-SERCA2a), to heart…
- Trial name
- SERCA-LVAD (NCT00534703)
- Testing
- AAV1/SERCA2a
- Where
- 2 sites in United Kingdom
- Volunteers
- 5 people
- Sponsor
- Imperial College London
Pacemaker Malfunction
Human Use Condition Study- Evaluation of Implanted Leads in Humans
The purpose of this study is to evaluate different types of leads (wires) that are connected to your pacemaker (an implanted device which assists your heart function) to understand how the shape and motion of your previously…
- Trial name
- HUCS (NCT04320849)
- Where
- 5 sites in United States
- Volunteers
- 117 people
- Sponsor
- Duke University
Heart Failure
Model 4396 Left Ventricular (LV) Lead Study
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective.
- Trial name
- 4396 (NCT00853593)
- Testing
- Pacing Lead
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 197 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Gastrointestinal Bleeding
Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD
This study evaluates the efficacy of high-dose fish oil in decreasing rates of gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices.
- Trial name
- NCT03784963
- Testing
- Omega 3 fatty acids
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Chicago
Heart Failure
Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction
This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).
- Trial name
- NCT02788747
- Testing
- 4 mg elamipretide, 40 mg elamipretide
- Where
- 15 sites in Italy, Netherlands and 1 more
- Volunteers
- 71 people
- Sponsor
- Stealth BioTherapeutics Inc.
Heart Failure, Congestive, Myocardial Infarction
IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical…
- Conditions
- Heart Failure, Congestive, Myocardial Infarction, Ventricular Dysfunction, Left
- Trial name
- IMPROVE-HF (NCT00303979)
- Where
- 144 sites in United States
- Volunteers
- 34,810 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
- Trial name
- ERASE (NCT04600921)
- Testing
- Ertugliflozin 5 mg
- Where
- 8 sites in Austria
- Volunteers
- 55 people
- Sponsor
- Medical University of Graz
Heart Failure, Cardiomyopathy
The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe.
- Conditions
- Heart Failure, Cardiomyopathy, Ventricular Dysfunction
- Trial name
- NCT01442129
- Testing
- MPC Intramyocardial injection, Control Solution
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Deborah Ascheim
Heart Failure
Attain Stability™ Quad Clinical Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
- Trial name
- NCT03099655
- Testing
- Attain Stability Quad Left Ventricular Pacing Lead
- Where
- 50 sites in United States, Canada and 8 more
- Volunteers
- 471 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure
His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
The goal of this study is to compare the effectiveness of pacing from a physiologic His bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in subjects with heart failure undergoing cardiac…
- Trial name
- His-SYNC (NCT02700425)
- Testing
- CRT Pacemaker
- Where
- 8 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of Chicago