Clinical trials: Left Heart Failure
Heart Failure, Anemia
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in…
- Conditions
- Heart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction
- Trial name
- NCT00358215
- Testing
- Darbepoetin alfa
- Where
- 754 sites in United States, Argentina and 34 more
- Volunteers
- 2,278 people
- Sponsor
- Amgen
Advanced Heart Failure
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04915924
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 22 sites in South Korea
- Volunteers
- 358 people
- Sponsor
- Abbott Medical Devices
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 IDE Clinical Study Protocol
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
- Trial name
- HM3™ (NCT02224755)
- Testing
- HeartMate 3 LVAS, HeartMate II LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,028 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Left-Sided Heart Failure
CardioMEMS HF System Post Approval Study
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
- Conditions
- Heart Failure, Left-Sided Heart Failure, Congestive Heart Failure
- Trial name
- NCT02279888
- Testing
- CardioMEMS HF System
- Where
- United States
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead.
- Trial name
- CELESTIAL (NCT00810264)
- Testing
- CRT Therapy - LV Lead Registry
- Where
- 86 sites in United States
- Volunteers
- 2,499 people
- Sponsor
- Biotronik, Inc.
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
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
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
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
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
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
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
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
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 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