Clinical trials: Heart Ventricles
Aortic Valve Stenosis
VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04655742
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Heart Failure, Left Ventricle Remodeling
ALIVE Expended Access - Clinical Study
A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.
- Trial name
- ALIVE-EA (NCT05710042)
- Testing
- Revivent TC System
- Where
- 2 sites in United States
- Sponsor
- BioVentrix
Heart Defect, Congenital
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract…
- Trial name
- Xplore2 (NCT03022708)
- Testing
- Xeltis Bioabsorbable Pulmonary Valved Conduit
- Where
- 10 sites in United States, Bulgaria and 2 more
- Volunteers
- 6 people
- Sponsor
- Xeltis
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) versus placebo in adults with symptomatic hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction.
- Trial name
- SEQUOIA-HCM (NCT05186818)
- Testing
- Aficamten (5 mg, 10 mg, 15 mg, and 20 mg)
- Where
- 114 sites in United States, China and 12 more
- Volunteers
- 282 people
- Sponsor
- Cytokinetics
Hypertension, Pulmonary, Heart Failure With Reduced Ejection Fraction
Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG
This is a prospective, observational study evaluating whether heart sounds (phonocardiograms) and three-lead electrocardiograms (ECGs) recorded using the Eko CORE 500 digital stethoscope can help detect pulmonary hypertension…
- Trial name
- PH ELEFT 2-0 (NCT07087613)
- Testing
- Eko CORE 500 Digital Stethoscope
- Where
- 4 sites in United States
- Volunteers
- 3,850 people
- Sponsor
- Eko Devices, Inc.
Diabetes Type 2, Hyperglycaemia (Diabetic)
Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM
Diabetes is a significant risk factor for sudden cardiac death, with the QTc interval on electrocardiograms (ECGs) often prolonged in diabetic patients due to factors such as hyperglycaemia and insulin resistance.
- Conditions
- Diabetes Type 2, Hyperglycaemia (Diabetic), QT Interval, Variation in, Torsades de Pointes
- Trial name
- NCT07014735
- Testing
- glucose, moxifloxacin
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Richmond Pharmacology Limited
Advanced Heart Failure
CorWave LVAS FIH Study
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and effectiveness of the CorWave LVAS for the treatment of advanced heart failure patients.
- Trial name
- NCT06907017
- Testing
- LVAS
- Where
- 3 sites in Australia, Kazakhstan
- Volunteers
- 20 people
- Sponsor
- CorWave
Implantable Cardioverter Defibrillator(ICD)
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
- Trial name
- BIO|ATP (NCT05426785)
- Testing
- 1:1 ratio for Treatment Group and Control Group
- Where
- Japan
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
Renal Transplant
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant…
- Trial name
- EVITA (NCT01169701)
- Testing
- Everolimus, Tacrolimus, Mycophenolic acid (MPA)
- Where
- 9 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sudden Cardiac Death, Left Ventricular Dysfunction
LifeVest Safety and Efficacy in Real Life Settings in France
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
- Conditions
- Sudden Cardiac Death, Left Ventricular Dysfunction, Cardiac Event, Cardiac Arrythmias
- Trial name
- WEARIT-FR (NCT03319160)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 2 sites in France
- Volunteers
- 1,164 people
- Sponsor
- Zoll Medical Corporation
Ventricular Fibrillation, Ventricular Tachycardia
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output
- Trial name
- UNTOUCHED (NCT02433379)
- Testing
- EMBLEM S-ICD System
- Where
- 110 sites in United States, Belgium and 11 more
- Volunteers
- 1,173 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation, Ventricular Tachycardia
Advisor HD Grid Observational Study
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called…
- Trial name
- NCT03733392
- Testing
- Advisor HD Grid Mapping Catheter, Sensor Enabled
- Where
- 25 sites in Australia, Austria and 9 more
- Volunteers
- 379 people
- Sponsor
- Abbott Medical Devices
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Chronic Heart Failure
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131…
- Trial name
- NCT02814097
- Testing
- elamipretide
- Where
- 9 sites in Germany, Serbia
- Volunteers
- 46 people
- Sponsor
- Stealth BioTherapeutics Inc.
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- COSMOS (NCT05373862)
- Testing
- Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 4 sites in Belgium, Croatia and 1 more
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Ventricular Tachycardia, Ventricular Fibrillation
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
- Trial name
- DATAS (NCT00157820)
- Testing
- Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System
To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical…
- Trial name
- NCT03043404
- Testing
- Transcatheter aortic valve replacement
- Where
- 2 sites in Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Heart Failure
Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates
Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist…
- Trial name
- TRIV (NCT00887237)
- Testing
- CRT with triple site ventricular stimulation, Conventional cardiac resynchronization
- Where
- 12 sites in France
- Volunteers
- 76 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure