Clinical trials: Left Ventricular Failure
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension…
- Conditions
- Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension, Vascular Diseases
- Trial name
- PADN-HF-PH (NCT05824923)
- Testing
- Pulmonary arterial denervation, Guideline-directed medical therapy (GDMT) for heart failure
- Where
- China
- Volunteers
- 264 people
- Sponsor
- Pulnovo Medical (Wuxi) Co., Ltd.
Heart Failure
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System
This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).
- Trial name
- COMPETENCE (NCT01187368)
- Testing
- EVAHEART Left Ventricular Assist System (LVAS), HeartMate 3
- Where
- 12 sites in United States
- Volunteers
- 399 people
- Sponsor
- Evaheart, Inc.
Cardiomyopathy Due to Drug, Heart Failure, Systolic
Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy.
The intent of the study is to show the potential benefits of angiotensin converting enzyme inhibitors in preventing anthracycline induced cardiotoxicity.
- Trial name
- NCT03392740
- Testing
- Lisinopril
- Where
- United States
- Sponsor
- Ascension Health
Diabetes Mellitus, Heart Failure
Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular…
- Trial name
- NCT01440517
- Testing
- Tc99m-Maraciclatide
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- GE Healthcare
Heart Failure
EASYTRAK 4 Steerable LV Lead
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
- Trial name
- NCT00158964
- Testing
- EASYTRAK 4 STEERABLE LV lead
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Boston Scientific Corporation
End-stage Heart Failure
Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.
- Trial name
- NCT05353816
- Testing
- Corheart 6 Left Ventricular Assist System
- Where
- 11 sites in China
- Volunteers
- 50 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Heart Failure
Care-HF CArdiac Resynchronization in Heart Failure
The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal…
- Trial name
- NCT00170300
- Testing
- Implantable Cardiac Resynchronisation (pacing) device
- Volunteers
- 813 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Cardiac Arrhythmia
Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization
BIO|Adapt study is designed to provide evidence for the clinical benefit of the CRT AutoAdapt feature. This feature provides continuous adaptation of AV delay and biventricular pacing modality.
- Conditions
- Heart Failure, Cardiac Arrhythmia, Left Ventricular Dysfunction
- Trial name
- BIO|Adapt (NCT04774523)
- Testing
- Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Echocardiography AV optimization, Echocardiography
- Where
- Spain
- Volunteers
- 198 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.
- Trial name
- Promote Q (NCT00990665)
- Testing
- CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
- Where
- 24 sites in United States
- Volunteers
- 178 people
- Sponsor
- Abbott Medical Devices
Pulmonary Hypertension
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
- Trial name
- LEVEL (NCT05983250)
- Testing
- TNX-103
- Where
- 42 sites in United States, Canada
- Volunteers
- 230 people
- Sponsor
- Tenax Therapeutics, Inc.
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Heart Failure, Left Sided
ContraBand™: Safety & Feasibility Study (RM-20-01)
ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in…
- Trial name
- NCT05230745
- Testing
- ContraBand implants
- Where
- 12 sites in Belgium, Georgia and 4 more
- Volunteers
- 55 people
- Sponsor
- Restore Medical Ltd
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3™ CE Mark Clinical Investigation Plan
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical…
- Trial name
- HM3 CE Mark (NCT02170363)
- Testing
- Left Ventricular Assist System (LVAS)
- Where
- 10 sites in Australia, Austria and 4 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Acute Myocardial Infarction, Congestive Heart Failure
IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous…
- Conditions
- Acute Myocardial Infarction, Congestive Heart Failure, ST-Elevation Myocardial Infarction
- Trial name
- PRESERVATION-1 (NCT01226563)
- Testing
- IK-5001, Saline Solution
- Where
- 82 sites in United States, Australia and 7 more
- Volunteers
- 303 people
- Sponsor
- Bellerophon BCM LLC
Heart Failure
C-Pulse® System: A Heart Assist Device Clinical Study
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse").
- Trial name
- COUNTER-HF (NCT01740596)
- Testing
- C-Pulse® System Counterpulsation
- Where
- 28 sites in United States
- Volunteers
- 38 people
- Sponsor
- Nuwellis, Inc.
Coronary Artery Disease, Heart Failure
Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients…
- Conditions
- Coronary Artery Disease, Heart Failure, High-risk PCI
- Trial name
- NCT06754839
- Testing
- Percutaneous left ventricular assist device(Ventiflow LP), VA-ECMO
- Volunteers
- 250 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Dilated Cardiomyopathy
Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery
This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular restoration in patients with dilated…
- Trial name
- NCT00847964
- Testing
- Algisyl-LVR
- Where
- 3 sites in Germany, Poland
- Volunteers
- 11 people
- Sponsor
- LoneStar Heart, Inc.
Heart Failure With Reduced Ejection Fraction
Improving CRT Outcome With Non-Invasive Cardiac Mapping
The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement.
- Trial name
- ICONIC-M (NCT05564793)
- Testing
- Pre-implantation planning, Post-implantation assessment
- Where
- 11 sites in Netherlands, Portugal and 2 more
- Volunteers
- 330 people
- Sponsor
- EP Solutions SA
Heart Failure
Evaluation of Left Ventricular AutoThreshold
This study will collect data on a new feature for future heart failure devices via an external non-implantable system.
- Trial name
- ELEVATE (NCT00812201)
- Testing
- No intervention is used. Collection of signals only.
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Boston Scientific Corporation
Myocardial Infarction, Heart Failure
A Study of VentriGel in Post-MI Patients
This Phase I, open label, study will investigate the effects of VentriGel injection in patients who have experienced a first, large ST elevation myocardial infarction (STEMI) treated by PCI within the past 3 years and have…
- Conditions
- Myocardial Infarction, Heart Failure, Left Ventricular Remodeling
- Trial name
- NCT02305602
- Testing
- VentriGel
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Ventrix, Inc.