Clinical trials: Left Heart Failure
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
Left Ventricular Dysfunction, Heart Failure
INcrease Of VAgal TonE in CHF
The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart Failure.
- Trial name
- INOVATE-HF (NCT01303718)
- Testing
- CardioFit® System, Standard of Care
- Where
- 87 sites in United States, Belgium and 6 more
- Volunteers
- 730 people
- Sponsor
- BioControl Medical
Hypertension, Pulmonary, Heart Failure
The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC
In patients with heart failure, elevated filling pressures may contribute to symptoms while not improving cardiac output. The current study is focused on evaluating the relationship between exercise capacity, pulmonary pressures…
- Trial name
- NCT02984631
- Testing
- Preventing pulm HTN during exercise
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cardioflow Technologies, LLC
Heart Failure
Left Ventricular MultiSpot Pacing for CRT (iSPOT)
The purpose of the iSPOT Study is to evaluate the contractility using positive left ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac resynchronization therapy (CRT).
- Trial name
- iSPOT (NCT01883141)
- Testing
- Electrophysiological Study
- Where
- 8 sites in Belgium, Israel and 2 more
- Volunteers
- 31 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Heart Failure
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with…
- Trial name
- RELAX-Cardio (NCT02625922)
- Testing
- Serelaxin
- Where
- 9 sites in Germany, Switzerland and 1 more
- Volunteers
- 26 people
- Sponsor
- Novartis Pharmaceuticals
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
Heart Failure
Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.
- Trial name
- ORPHEE (NCT03127202)
- Testing
- Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)
- Where
- 12 sites in France
- Volunteers
- 90 people
- Sponsor
- LivaNova
Heart Failure
Acute Response to Left Bundle Branch Area Pacing With SyncAV
This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left…
- Trial name
- NCT06436053
- Testing
- LBBAP with SyncAV
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone
This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with…
- Trial name
- ARTS-HF Japan (NCT01955694)
- Testing
- BAY94-8862, Eplerenone
- Where
- 29 sites in Japan
- Volunteers
- 72 people
- Sponsor
- Bayer
Heart Failure
Model 4296 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. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms.
- Trial name
- 4296 (NCT00927251)
- Testing
- Pacing Lead (Model 4296 LV Lead)
- Where
- 16 sites in Austria, Finland and 6 more
- Volunteers
- 90 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORE (NCT07188805)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 133 sites in United States, Argentina and 21 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Heart Failure With Left Bundle Branch Block
AdaptResponse Clinical Trial
The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT…
- Trial name
- NCT02205359
- Testing
- aCRT ON, aCRT OFF
- Where
- 220 sites in United States, Australia and 26 more
- Volunteers
- 3,797 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT Indications
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy (CRT), in Chinese Heart Failure (HF)…
- Trial name
- NCT03071978
- Testing
- CRT with LV-only pacing / bi-ventricular pacing
- Where
- 5 sites in China
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Postoperative Cardiac Complication, Heart Failure
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and…
- Conditions
- Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation
- Trial name
- MORE-CRT (NCT01510652)
- Testing
- BiP Group, Quad Group
- Where
- 64 sites in Belgium, Canada and 11 more
- Volunteers
- 1,078 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Left Ventricular Systolic Dysfunction
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period.
- Trial name
- NCT05714085
- Testing
- Vericiguat tablet, Vericiguat suspension
- Where
- 111 sites in United States, Belgium and 28 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
Symptomatic Decompensated Congestive Heart Failure, Congestive Heart Failure in Acute Coronary Syndrome
A Study Comparing Blood Flow and Clinical and Safety Effects of the Addition of Natrecor (Nesiritide), Placebo or Intravenous Nitroglycerin to Standard Care for the Treatment of Worsening Congestive Heart Failure.
The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to…
- Trial name
- NCT00270374
- Testing
- nesiritide
- Volunteers
- 498 people
- Sponsor
- Scios, Inc.
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
Right Heart Failure, Left Ventricular Assist Device
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an LVAD.
- Trial name
- NCT03217331
- Testing
- CRD-102
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cardiora Pty. Ltd.
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and…
- Conditions
- Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension, Vascular Diseases
- Trial name
- The PULSE-LHD (NCT07214376)
- Testing
- Pulmonary Artery Denervation (PADN)
- Where
- 18 sites in United States, China
- Volunteers
- 750 people
- Sponsor
- Pulnovo Medical, Inc.