Clinical trials: Ventricular Failure
Heart Failure
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional…
- Trial name
- INTELLECT 2-HF (NCT03247829)
- Testing
- Hemodynamic management using CardioMEMS HF System
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac…
- Trial name
- NCT00396136
- Testing
- Corox OTW Steroid Left Ventricular Lead
- Where
- United States
- Volunteers
- 221 people
- Sponsor
- Biotronik, 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, Ventricular Dysfunction
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients…
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- Trial name
- NCT00187213
- Testing
- Cardiac Resynchronization Therapy
- Where
- France
- Sponsor
- Abbott Medical Devices
Heart Failure, Tachyarrhythmia
Iperia/Sentus QP Study
The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
- Trial name
- NCT02181686
- Where
- 24 sites in Austria, Denmark and 9 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Dilated Cardiomyopathy (DCM), Ischemic Cardiomyopathy
Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)
To determine the safety profile of CAP-1002 administered by multi-vessel intracoronary infusion in subjects with DCM. The study will further explore safety and exploratory efficacy endpoints of CAP-1002.
- Conditions
- Dilated Cardiomyopathy (DCM), Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy, Heart Failure
- Trial name
- DYNAMIC (NCT02293603)
- Testing
- Allogeneic Cardiosphere-Derived Cells (CDCs)
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Capricor Inc.
Heart Failure
Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study
Lead survivability will be summarized.
- Trial name
- NCT02294331
- Where
- 100 sites in United States, Belgium and 6 more
- Volunteers
- 1,900 people
- Sponsor
- Medtronic
Heart Failure
EASYTRAK 3 Downsize Lead
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.
- Trial name
- NCT00384722
- Testing
- EASYTRAK 3 Downsize Lead
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic…
- Conditions
- Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure, History of Chronic Heart Failure
- Trial name
- COSMIC-HF (NCT01786512)
- Testing
- Omecamtiv Mecarbil Matrix F1 Formulation, Omecamtiv Mecarbil Matrix F2 Formulation, Omecamtiv Mecarbil Swellable Core Technology F2
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 544 people
- Sponsor
- Cytokinetics
Congestive Heart Failure
A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure
The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.
- Trial name
- COMPARE (NCT00323037)
- Testing
- carvedilol controlled release, carvedilol immediate release
- Where
- 75 sites in United States
- Volunteers
- 318 people
- Sponsor
- CTI-1, LLC
Heart Failure
Evaluation of Left Ventricular Autothreshold, Phase Two
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
- Trial name
- ELEVATE 2 (NCT01242722)
- Testing
- CRT-D
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Severe Functional Mitral Regurgitation and Heart Failure
Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function
To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.
- Trial name
- LVRECOVER (NCT02153892)
- Testing
- GDS Accucinch System
- Where
- Australia
- Volunteers
- 2 people
- Sponsor
- Ancora Heart, Inc.
Heart Failure, Cardiac Failure
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure, Heart Failure, Left-sided
- Trial name
- NCT02205411
- Testing
- HeartAssist 5® VAD System, Control VAD
- Where
- 14 sites in United States
- Volunteers
- 17 people
- Sponsor
- ReliantHeart Inc.
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 IDE Clinical Study Protocol
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
- Trial name
- HM3™ (NCT02224755)
- Testing
- HeartMate 3 LVAS, HeartMate II LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,028 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US.
- Trial name
- QP ExCELs (NCT02290028)
- Testing
- Sentus QP left ventricular lead
- Where
- 119 sites in United States, Australia and 9 more
- Volunteers
- 2,226 people
- Sponsor
- Biotronik SE & Co. KG
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
Aortic Stenosis
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- RESTORE (NCT06777368)
- Testing
- Medtronic TAV, Edwards TAV
- Where
- 71 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiovascular
Right Heart Failure
Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure
The goal of this clinical trial is to evaluate the safety and feasibility of the CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) in patients with right heart failure who continue to experience hemodynamic…
- Trial name
- NCT07704424
- Testing
- CorVad Percutaneous Ventricular Assist System
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers…
- Trial name
- CAN-SAVE R (NCT01219621)
- Testing
- Symphony Dual Chamber Rate Responsive Device
- Where
- 10 sites in Canada
- Volunteers
- 450 people
- Sponsor
- Sorin Group Canada