Clinical trials: Left Heart Failure
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3 CE Mark Study Long Term Follow-up
The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS…
- Trial name
- HM3 CE LTFU (NCT03022461)
- Testing
- Long term follow-up
- Where
- 8 sites in Australia, Austria and 4 more
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Heart Failure
QuickFlex Micro Left Ventricular Lead Post Approval Study
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
- Trial name
- NCT01179477
- Testing
- Implantation of a QuickFlex® μ Model 1258T LV Lead
- Where
- 77 sites in United States
- Volunteers
- 1,930 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121485
- Testing
- Left Ventricular Assist System (LVAS)
- Where
- 47 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Failure
NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation
Background: Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral valve heart problems. But the usual TMVR techniques might cause an obstruction for some people.
- Trial name
- NCT03015194
- Testing
- Edwards SAPIEN 3 transcatheter heart valve, ASHI INTECC Astato XS 20
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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
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
Cardiomyopathies, Congestive Heart Failure
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.
- Trial name
- NCT03253809
- Testing
- Biotronik Vision Guidewire
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- The Cleveland Clinic
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, LVAD
The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
- Trial name
- LVAD-ON-OFF (NCT04219618)
- Testing
- Off-Pump, On-Pump
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
Acute Decompensated Heart Failure, Sleep Disordered Breathing
Cardiovascular Improvements With MV ASV Therapy in Heart Failure
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF.
- Trial name
- CAT-HF (NCT01953874)
- Testing
- MV ASV, Optimized Medical Treatment
- Where
- 15 sites in United States, Germany
- Volunteers
- 126 people
- Sponsor
- ResMed
Chronic Heart Failure
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe…
- Trial name
- SHIFT (NCT02441218)
- Testing
- Ivabradine
- Where
- 2 sites in France, Sweden
- Volunteers
- 6,505 people
- Sponsor
- Institut de Recherches Internationales Servier
Congestive Heart Failure, LV Dysfunction
Dual Site Left Ventricular (LV) Pacing
The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing: 1. Improves the way the heart's left ventricle functions 2.
- Trial name
- DIVA (NCT00944125)
- Testing
- Dual Site LV Pacing, BiV Pacing
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Wake Forest University Health Sciences
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 Failure (HF)
A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction.
This study is a prospective, open-label, single-arm intervention study in African-American/Black subjects with heart failure and reduced ejection fraction (HFrEF).
- Trial name
- NCT03456856
- Testing
- Ivabradine
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Amgen
Chronic Kidney Disease, Left Ventricular Hypertrophy
The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48 weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular hypertrophy (LVH).
- Trial name
- PRIMO (NCT00497146)
- Testing
- paricalcitol
- Where
- 71 sites in United States, Australia and 10 more
- Volunteers
- 227 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Myocardial Infarction
Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.
- Trial name
- ALLSTAR (NCT01458405)
- Testing
- CAP-1002 Allogeneic Cardiosphere-Derived Cells
- Where
- 32 sites in United States
- Volunteers
- 135 people
- Sponsor
- Capricor Inc.
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
Atrial Fibrillation, Ventricular Tachycardia
An Assessment of Dual Site Left Ventricular Endocardial Pacing
We are investigating ways to help patients with heart failure, which is caused by damaged hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of energy and swelling.
- Conditions
- Atrial Fibrillation, Ventricular Tachycardia, Heart Failure
- Trial name
- DOUBLE-CRT (NCT02211456)
- Testing
- Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Oxford University Hospitals NHS Trust
Heart Failure
Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement
The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future.
- Trial name
- ASSURANCE (NCT00869024)
- Testing
- Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Minnesota