Clinical trials: Heart Ventricles
Heart Failure
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study.
- Trial name
- Microtech-LVAD (NCT06682910)
- Testing
- Microtech sensor pressure
- Where
- 2 sites in United States, Israel
- Volunteers
- 15 people
- Sponsor
- Microtech Medical Technologies, Ltd
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Tachycardia, Ventricular
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory…
- Trial name
- RADIATE-VT (NCT05765175)
- Testing
- Varian Cardiac Radioablation (CRA), Catheter Ablation (CA)
- Where
- 12 sites in United States
- Volunteers
- 380 people
- Sponsor
- Varian, a Siemens Healthineers Company
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Heart Failure
Care-HF CArdiac Resynchronization in Heart Failure
The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal…
- Trial name
- NCT00170300
- Testing
- Implantable Cardiac Resynchronisation (pacing) device
- Volunteers
- 813 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Arrhythmia, Tachycardia
Enlighten Study: The EV-ICD Post Approval Registry
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.
- Trial name
- NCT06048731
- Testing
- Defibrillation using EV-ICD
- Where
- 130 sites in United States, Austria and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic
Ventricular Tachycardia, Ventricular Fibrillation
Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.
- Trial name
- SPICE (NCT00745745)
- Testing
- Device Implantation
- Where
- 21 sites in Germany, Greece
- Volunteers
- 299 people
- Sponsor
- Abbott Medical Devices
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Heart Failure, Sleep Disordered Breathing
Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure
The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic…
- Trial name
- Serve-HF (NCT00733343)
- Testing
- Europe: AutoSet CS (USA: VPAP Adapt SV)
- Where
- 267 sites in Australia, Czechia and 9 more
- Volunteers
- 1,325 people
- Sponsor
- ResMed
Heart Failure, Cardiomyopathies
Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study
This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or…
- Trial name
- NCT03183895
- Testing
- Left ventricular restoration
- Where
- 19 sites in Belarus, Belgium and 8 more
- Volunteers
- 132 people
- Sponsor
- Ancora Heart, Inc.
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Heart Failure
AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure
To determine the safety and efficacy of an intracoronary injection of adenovirus 5 encoding human adenylyl cyclase 6 (RT-100) in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) in a Phase 3…
- Trial name
- FLOURISH (NCT03360448)
- Testing
- Ad5.hAC6
- Sponsor
- Renova Therapeutics
Chronic Heart Failure
Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure
The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived mesenchymal precursor cells (MPCs [rexlemestrocel-L]) is effective in the treatment of chronic heart…
- Trial name
- DREAM HF-1 (NCT02032004)
- Testing
- Rexlemestrocel-L
- Where
- 59 sites in United States, Canada
- Volunteers
- 565 people
- Sponsor
- Mesoblast, Inc.
Ventricular Tachycardia
Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study
This study will assess the outcomes of using magnetic navigation to treat ventricular tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons and are not related to structural heart disease.
- Trial name
- NCT01401608
- Testing
- RF Ablation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Stereotaxis
Ventricular Tachycardia
VT Ablation in the iCMR
The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with…
- Trial name
- VISABL-VT (NCT05543798)
- Testing
- Vision-MR Ablation Catheter 2.0
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 64 people
- Sponsor
- Imricor Medical Systems
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Tachycardia, Ventricular
Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction…
- Trial name
- MAGNETIC-VT (NCT02637947)
- Testing
- catheter ablation using magnetic navigation, catheter ablation using manual navigation
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 182 people
- Sponsor
- Stereotaxis
Atrial Fibrillation (AF), Atrial Premature Complexes
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
The goal of this clinical trial is to evaluate the safety and efficacy of medical device Kardi Ai, an ECG telemetry monitoring device in adult population.
- Conditions
- Atrial Fibrillation (AF), Atrial Premature Complexes, Ventricular Premature Complexes, Bradycardia
- Trial name
- Kardi Ai (NCT07018648)
- Testing
- Medical device
- Where
- 2 sites in Czechia
- Volunteers
- 115 people
- Sponsor
- KARDI AI Technologies s.r.o.
Aortic Valve Calcification, Aortic Valve Stenosis
VALVOSOFT® Pivotal Study
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
- Trial name
- NCT05235568
- Testing
- VALVOSFT intervention
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Cardiawave SA