Clinical trials: Left Heart Failure
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
Heart Failure, Right-Sided, Cardiac Failure
Syncardia 50cc TAH-t as a Bridge to Transplant
The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support…
- Conditions
- Heart Failure, Right-Sided, Cardiac Failure, Heart Failure, Left-Sided
- Trial name
- NCT02459054
- Testing
- SynCardia 50cc temporary Total Artificial Heart (TAH-t)
- Where
- 26 sites in United States
- Volunteers
- 16 people
- Sponsor
- SynCardia Systems. LLC
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
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria.
- Trial name
- NCT01627821
- Testing
- Jarvik 2000 VAS, HeartMate II
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Jarvik Heart, Inc.
Heart Failure
V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heaRt Failure
The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™ System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.
- Trial name
- VECTOR-HF (NCT03775161)
- Testing
- V-LAP™ System
- Where
- 2 sites in Germany, Italy
- Volunteers
- 45 people
- Sponsor
- Vectorious Medical Technologies Ltd.
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
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, Left Ventricular Dysfunction
PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE.
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.
- Trial name
- P5 (NCT02543632)
- Testing
- Parachute Implant System
- Where
- 10 sites in Germany
- Volunteers
- 85 people
- Sponsor
- CardioKinetix, Inc
Refractory Heart Failure, Cardiovascular Diseases (CVD)
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory…
- Trial name
- BRIOLIFE (NCT07252531)
- Testing
- LVAD implantation
- Where
- 2 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- BrioHealth BV
Congestive Heart Failure
The V-Wave Shunt: FIM Safety and Feasibility Study
The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF)…
- Trial name
- VW-SP-1 (NCT01965015)
- Testing
- Implantation of the V-Wave inter-atrial shunt
- Where
- 6 sites in Germany, Israel and 1 more
- Volunteers
- 16 people
- Sponsor
- V-Wave Ltd
Ischemic Heart Failure
PARACHUTE China Approval Trial
The design of this study is a multi-center, prospective, single-arm clinical trial to evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning system.
- Trial name
- NCT02240940
- Testing
- Parachute Implant
- Where
- 7 sites in China
- Volunteers
- 30 people
- Sponsor
- CardioKinetix, Inc
Heart Failure, Dilated Cardiomyopathy
A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with…
- Trial name
- AUGMENT-HF (NCT01311791)
- Testing
- Algisyl-LVR, Standard medical therapy
- Where
- 18 sites in Australia, Germany and 4 more
- Volunteers
- 78 people
- Sponsor
- LoneStar Heart, 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
PORTHOS - PORTuguese Heart Failure Observational Study
This study aims to determine the prevalence of heart failure in the resident population in mainland Portugal aged 50 years or above, using a contemporary, guideline-based diagnostic approach, to optimize patient management and…
- Trial name
- PORTHOS (NCT05434923)
- Where
- 13 sites in Portugal
- Volunteers
- 6,189 people
- Sponsor
- AstraZeneca
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
Heart Failure
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart…
- Trial name
- LAPTOP-HF (NCT01121107)
- Testing
- Left Atrial Pressure Monitoring System, Patient Advisory Module
- Where
- 64 sites in United States, New Zealand
- Volunteers
- 486 people
- Sponsor
- Abbott Medical Devices
Heart Failure
NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
A Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYA™ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd.
- Trial name
- NCT05375110
- Testing
- NoYA™ Radiofrequency Interatrial Shunt System
- Where
- 31 sites in China
- Volunteers
- 120 people
- Sponsor
- Hangzhou NOYA MedTech Co. Ltm.
Chronic Heart Failure, Left Ventricular (LV) Systolic Dysfunction
A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure
This study evaluates the safety and performance/effectiveness of the C-MIC System, an active implantable medical device designed to treat patients with heart failure with reduced ejection fraction (HFrEF).
- Conditions
- Chronic Heart Failure, Left Ventricular (LV) Systolic Dysfunction, Ischemic and Non-ischemic Cardiomyopathy
- Trial name
- NCT07795359
- Testing
- Subcutaneous cardiac microcurrent treatment
- Volunteers
- 60 people
- Sponsor
- Berlin Heals GmbH
Acute Decompensated Heart Failure
IC14 for Treatment of Acute Decompensated Heart Failure
The goal of this clinical trial is to learn if drug atibuclimab (IC14) works to treat adults hospitalized with acute decompensated heart failure (ADHF). It will also learn about the safety of IC14.
- Trial name
- NCT06556810
- Testing
- Atibuclimab (IC14)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Implicit Bioscience
Heart Failure
Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.
- Trial name
- NCT00710567
- Testing
- DuraHeart Left Ventricular Assist System (LVAS)
- Where
- 26 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Terumo Heart Inc.