Clinical trials: Heart Ventricles
Aortic Valve Stenosis
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients.
- Trial name
- NCT02434263
- Testing
- Hydra TAVI
- Where
- 6 sites in Greece, Hong Kong and 4 more
- Volunteers
- 165 people
- Sponsor
- Vascular Innovations Co. Ltd.
Congestive Heart Failure
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
Use of the EnSite NavX system to map the coronary vasculature during CRT implant
- Trial name
- Bi-VNavX (NCT01615835)
- Testing
- EnSite NavX System
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Abbott Medical Devices
Arrhythmogenic Right Ventricular Cardiomyopathy
Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC
This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
- Trial name
- RIDGE-1 (NCT06228924)
- Testing
- TN-401
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- Tenaya Therapeutics
Ventricular Arrythmia, Ventricular Tachycardia
Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices.
- Conditions
- Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Trial name
- NCT05791032
- Testing
- AtaCor EV-ICD Lead
- Where
- Paraguay
- Volunteers
- 21 people
- Sponsor
- AtaCor Medical, Inc.
Heart Failure
EASYTRAK 4 Steerable LV Lead
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
- Trial name
- NCT00158964
- Testing
- EASYTRAK 4 STEERABLE LV lead
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
This study is researching an experimental drug called REGN5381, further referred to as study drug. The study is focused on adult participants with heart failure that, in the opinion of the study doctor, have a clinical indication…
- Trial name
- NCT05353166
- Testing
- REGN5381
- Where
- Moldova
- Volunteers
- 59 people
- Sponsor
- Regeneron Pharmaceuticals
Severe Aortic Stenosis
SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.
- Trial name
- SAFE-TAVI (NCT05492383)
- Testing
- TAVI
- Where
- 6 sites in Spain
- Volunteers
- 119 people
- Sponsor
- Opsens, Inc.
Tachycardia, Ventricular, Cardiac Sudden Death
The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events
This is a prospective study to evaluating the ability of the PD2i Cardiac Analyzer to predict the risk of serious heart rhythm abnormalities in high-risk patients that do not already have an Implantable Cardioverter Defibrillator.
- Trial name
- VITAL (NCT00510731)
- Where
- 19 sites in United States
- Sponsor
- Vicor Technologies, Inc.
Heart Failure, Cardiovascular Diseases
Novel INXN-4001 Triple Effector Plasmid in Heart Failure
To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-related adverse events occurring…
- Conditions
- Heart Failure, Cardiovascular Diseases, Heart-Assist Device
- Trial name
- NCT03409627
- Testing
- INXN-4001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Triple-Gene, LLC
Ventricular Dysfunction, Left, Ventricular Function, Left
Federated Learning for Point-of-Care Cardiac Ultrasound
This prospective, multicenter study will evaluate a federated machine-learning system designed to analyze focused cardiac point-of-care ultrasound examinations.
- Conditions
- Ventricular Dysfunction, Left, Ventricular Function, Left, Echocardiography, Ultrasonography
- Trial name
- FL-POCUS (NCT07800962)
- Testing
- Focused Cardiac Point-of-Care Ultrasonography, FL-POCUS Federated Machine-Learning Analysis System
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Truway Health, Inc.
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
- Trial name
- SOURCE 3 (NCT02698956)
- Testing
- TAVI (Transcatheter Aortic Valve Implantation)
- Where
- 73 sites in Denmark, Finland and 8 more
- Volunteers
- 2,000 people
- Sponsor
- Edwards Lifesciences
Right Ventricular Outflow Tract Stenosis
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.
- Trial name
- NCT02071654
- Testing
- Venus P-valve transcatheter implantation
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Heart Failure
Placement of CS/LV Pacing Leads With EnSite NavX Guidance
This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of…
- Trial name
- NCT00577187
- Testing
- EnSite NavX-Guided CRT implant
- Where
- United States
- Sponsor
- Abbott Medical Devices
Myocardial Infarction, Arrhythmia, Ventricular
MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
The purpose of the study is to determine the usefulness of Microvolt T Wave Alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart.
- Conditions
- Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy
- Trial name
- NCT00305214
- Testing
- T Wave Alternans Test
- Where
- 47 sites in United States
- Volunteers
- 405 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis
The Leaflex™ Brazilian Standalone Study
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.
- Trial name
- NCT05052684
- Testing
- Leaflex™ Performer
- Where
- Brazil
- Volunteers
- 1 people
- Sponsor
- Pi-cardia
Myocardial Infarction
A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction
The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in patients with left-ventricular (LV)…
- Trial name
- CHIARA MIA 2 (NCT02976467)
- Testing
- Fulacimstat (BAY1142524)
- Where
- 25 sites in Czechia, Germany and 3 more
- Volunteers
- 107 people
- Sponsor
- Bayer
Aortic Valve Stenosis, Aortic Valve Disease
Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement
- Trial name
- NCT05295628
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS"), SENTINEL™ Cerebral Protection System
- Where
- 23 sites in United States
- Volunteers
- 532 people
- Sponsor
- Emblok, Inc.
Aortic Stenosis, Aortic Regurgitation
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM
- Trial name
- NCT03666351
- Testing
- Amlodipine 5mg, Losartan, Losartan and Amlodipine
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Amyloidosis
Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698
The study is intended to evaluate whether monthly repeated courses of administration of GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in patients with cardiac amyloidosis, monitored by…
- Trial name
- NCT03044353
- Testing
- GSK2315698 (CPHPC), GSK2398852 (anti-SAP mAb)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline