Clinical trials: Left Heart Failure
Heart Failure
REDUCE LAP-HFREF TRIAL
The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain…
- Trial name
- NCT03093961
- Testing
- IASD implant
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 10 people
- Sponsor
- Corvia Medical
Heart Failure
A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy
This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure.
- Trial name
- 8282-Reduced (NCT06979375)
- Testing
- CDR132L
- Where
- 92 sites in Australia, Czechia and 8 more
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Congestive Heart Failure, Left Ventricular (LV) Systolic Dysfunction
A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System
Treatment of ischemic heart failure.
- Trial name
- PARACHUTE IV (NCT01614652)
- Testing
- CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
- Where
- 68 sites in United States, Canada
- Volunteers
- 331 people
- Sponsor
- CardioKinetix, Inc
Heart Failure
Avicena LVDP Validation Study
The purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (LVDP) using the Vivio System, compared with invasively measured LVDP via direct measurement during…
- Trial name
- NCT05633004
- Testing
- Vivio
- Where
- United States
- Volunteers
- 406 people
- Sponsor
- Ventric Health, LLC
Heart Failure
REDUCE LAP-HF TRIAL II
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
- Trial name
- NCT03088033
- Testing
- IASD System II implant, intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
- Where
- 91 sites in United States, Australia and 13 more
- Volunteers
- 608 people
- Sponsor
- Corvia Medical
Heart Failure, Systolic Bundle Branch Block, Left
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator…
- Trial name
- ACHIEVED LBBAP (NCT07526896)
- Testing
- LBBAP Therapy, LOT-CRT, ICD
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Pulmonary Hypertension Associated With HFpEF
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular…
- Trial name
- LEVEL-2 (NCT07288398)
- Testing
- TNX-103
- Where
- 140 sites in United States, Argentina and 13 more
- Volunteers
- 540 people
- Sponsor
- Tenax Therapeutics, Inc.
Heart Failure, Left Bundle-Branch Block
LV Only MPP With SyncAV
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy…
- Trial name
- NCT03567096
- Testing
- BiV pacing with MPP and SyncAV, LV only pacing with MPP and SyncAV
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure, Congestive
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit from the device.
- Trial name
- NCT00370526
- Testing
- Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 100 people
- Sponsor
- Stereotaxis
Heart Failure
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not…
- Trial name
- ROADMAP (NCT01452802)
- Testing
- HM II (HeartMate II LVAD), OMM (Optimal Medical Management)
- Where
- 52 sites in United States
- Volunteers
- 200 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.
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
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study.
- Trial name
- NCT03305393
- Testing
- Adaptiv CRT
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stern Cardiovascular Foundation, 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
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
Heart Failure
REDUCE LAP-HF RANDOMIZED TRIAL I
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.
- Trial name
- NCT02600234
- Testing
- Inter-Atrial Shunt Device, Intracardiac Echo
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 44 people
- Sponsor
- Corvia Medical
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