Clinical trials: Heart Failure, Left Sided
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
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.
Heart Failure
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function.
- Trial name
- NCT00364598
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Theregen, Inc.
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.
Heart Failure
Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP
The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.
- Trial name
- NCT02099448
- Where
- Israel
- Volunteers
- 41 people
- Sponsor
- CorAlert Ltd.
Bradycardia, Right Ventricular Pacing
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
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, Heart Failure
Kosmos PLAX EF Pivotal Study
The purpose of this study is to validate the efficacy of Kosmos PLAX EF, an AI-assisted workflow that uses a cardiac ultrasound clip in Parasternal Long Axis (PLAX) cardiac view to calculate Left Ventricular Ejection Fraction…
- Conditions
- Heart, Heart Failure, Ejection Fraction, Left Ventricular Ejection Fraction
- Trial name
- NCT07771231
- Testing
- PLAX EF Manual vs. Automatic Measurement
- Where
- United States
- Volunteers
- 416 people, healthy volunteers welcome
- Sponsor
- EchoNous 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
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.
End-Stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
- Trial name
- NCT00490347
- Testing
- VentrAssist Left Ventricular Assist Device
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ventracor
Congestive Heart Failure
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB).
- Trial name
- NCT00060840
- Testing
- Nitric Oxide, Nitrogen
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Mallinckrodt
Current or Recent History of Atrial Fibrillation
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who…
- Trial name
- GENETIC-AF (NCT01970501)
- Testing
- bucindolol hydrochloride, metoprolol succinate
- Where
- 97 sites in United States, Canada and 4 more
- Volunteers
- 267 people
- Sponsor
- ARCA Biopharma, Inc.
Heart Failure With Reduced Ejection Fraction
First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction
It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that…
- Trial name
- CARDIOMESH (NCT03746938)
- Testing
- VB-C01
- Where
- 2 sites in Spain
- Volunteers
- 10 people
- Sponsor
- Viscofan
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, Congestive, Heart Decompensation
Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure
The study will evaluate the safety and efficacy of intravenous infusion of carperitide using pressure measurements inside the heart and great vessels and measuring carperitide concentration in the blood.
- Conditions
- Heart Failure, Congestive, Heart Decompensation, Left Ventricular Failure, Myocardiopathies
- Trial name
- NCT00259038
- Testing
- Carperitide
- Where
- 34 sites in United States, Canada
- Volunteers
- 162 people
- Sponsor
- Daiichi Sankyo
Heart Failure
A Prospective Pilot Study (BIO|SELECT Pilot)
Enrolled patients implanted with Biotronik CRT-D and QP lead equipped with MultiPole pacing mode is grouped into which programmed into MultiPole pacing, or conventional bi-ventricular pacing mode.
- Trial name
- NCT03337763
- Where
- Japan
- Volunteers
- 201 people
- Sponsor
- Biotronik SE & Co. KG
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, Systolic
Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes…
- Trial name
- PROVIDE-HF (NCT03387163)
- Testing
- Sacubitril/Valsartan
- Where
- United States
- Volunteers
- 402 people
- Sponsor
- Novartis Pharmaceuticals