Clinical trials: Left Side
Heart Failure, Cardiac Resynchronization Therapy
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.
- Trial name
- ASTRAL-4LV (NCT04463641)
- Testing
- Implantation of the Axone 4LV Lead
- Where
- 21 sites in Austria, France and 5 more
- Volunteers
- 92 people
- Sponsor
- MicroPort CRM
Heart Failure
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)
This study is a feasibility study of the HeartPOD™ Heart Failure Management System with DynamicRx® (HeartPOD system) in patients with severe chronic congestive heart failure.
- Trial name
- HOMEOSTASIS (NCT00547729)
- Testing
- HeartPOD™ System
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Chronic Kidney Disease (CKD) Stage 5, Hypertrophy, Left Ventricular
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).
- Trial name
- PRIMO II (NCT00616902)
- Testing
- paricalcitol injection 4 mcg/mL
- Where
- 76 sites in United States, Australia and 11 more
- Volunteers
- 12 people
- Sponsor
- Abbott
Atrial Fibrillation
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System
The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism…
- Trial name
- NCT04807283
- Testing
- Left Atrial Appendage Closure
- Where
- 4 sites in Georgia, Paraguay
- Volunteers
- 29 people
- Sponsor
- Laminar, Inc.
Bradycardia, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead…
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Cardiac Resynchronisation Therapy (CRT), ECG
- Trial name
- LBBOT (NCT07254013)
- Testing
- LBBAP implant
- Where
- 4 sites in France
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Pulmonary Hypertension Due to Left Heart Disease
A Study to Learn How Safe the Study Treatment BAY2701250 is, How it Affects the Body and How it Moves Into, Through and Out of the Body in Healthy Male Participants When a Single Amount is Given as an Injection Into the Vein (Intravenous Infusion) or Under the Skin (Subcutaneous Injection)
Researchers are looking for a better way to treat people who have pulmonary hypertension (PH) due to left heart disease. PH due to left heart disease is a condition of high blood pressure in the vessels of the lungs caused by…
- Trial name
- NCT06048120
- Testing
- BAY2701250 IV, BAY2701250 SC
- Where
- Germany
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Bayer
Advanced Refractory Left Ventricular Heart Failure
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS).
- Trial name
- SWIFT (NCT04548128)
- Testing
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Where
- 32 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Atrial Appendage
CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.
CLAARITY is a prospective, observational, single-arm, multi-center, post-market US study designed to evaluate the safety and performance of the ECLIPTIS clip in a minimum of 168 participants.
- Trial name
- CLAARITY (NCT07742839)
- Testing
- Edwards ECLIPTIS Left Atrial Appendage Exclusion System
- Volunteers
- 168 people
- Sponsor
- Edwards Lifesciences
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
Ischemic Stroke, Systemic Embolism
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of…
- Trial name
- LeAAPS (NCT05478304)
- Testing
- AtriClip LAA Exclusion System
- Where
- 138 sites in United States, Australia and 8 more
- Volunteers
- 6,573 people
- Sponsor
- AtriCure, Inc.
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.
Cardiac Disease
MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
Clinical validation study of the MyoVista wavECG.
- Trial name
- NCT04804969
- Testing
- MyoVista wavECG Test
- Where
- 5 sites in United States
- Volunteers
- 575 people
- Sponsor
- Heart Test Laboratories, Inc.
Ventricular Fibrillation, Ventricular Tachycardia
Left Ventricular Capture Management Study
Primary Objective: To characterize left ventricular (LV) threshold behavior over time using daily left ventricular capture management (LVCM) measurements.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Bradyarrhythmia
- Trial name
- LEARN (NCT01089634)
- Where
- Canada
- Volunteers
- 151 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure
A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to…
- Trial name
- NCT02388464
- Testing
- MTP-131
- Where
- Bulgaria
- Volunteers
- 36 people
- Sponsor
- Stealth BioTherapeutics Inc.
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.
Systolic Left Ventricular Dysfunction
The C-MIC-II Follow-Up Study
The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart.
- Trial name
- C-MIC-II-FU (NCT05189860)
- Testing
- C-MIC system
- Where
- 6 sites in Bosnia and Herzegovina, Croatia and 2 more
- Volunteers
- 31 people
- Sponsor
- Berlin Heals GmbH
Heart Failure, Congestive
Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular ejection fraction on radionuclide…
- Trial name
- NCT00240292
- Testing
- Rosuvastatin
- Where
- 13 sites in Australia
- Volunteers
- 160 people
- Sponsor
- AstraZeneca
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
Acute Non-ST Elevation Myocardial Infarction
DLBS1033 for Acute NSTEMI Without Early Coronary Revascularization
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without early coronary revascularization.
- Trial name
- NCT02146664
- Testing
- DLBS1033
- Where
- 2 sites in Indonesia
- Sponsor
- Dexa Medica Group
Heart Failure
ALLEVIATE-HFrEF Study
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using…
- Trial name
- NCT05133089
- Testing
- ALV1 System
- Where
- Georgia
- Volunteers
- 5 people
- Sponsor
- Alleviant Medical, Inc.