Clinical trials: Single-ventricle
Aortic Stenosis
transShield Embolic Protection System Feasibility Study
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT04585308
- Testing
- transShield Embolic Protection System
- Where
- 4 sites in New Zealand, Venezuela
- Volunteers
- 28 people
- Sponsor
- TransAortic Medical, Inc.
Hypertension, Cardiac Arrhythmias
Clinical Trial in Patients With Hypertension and Left Ventricular Dysfunction
Arterial hypertension causes adverse effects on the entire cardiovascular system, with effects centrally such as diastolic dysfunction and structural changes of the left ventricle and, peripherally such as endothelial dysfunction…
- Conditions
- Hypertension, Cardiac Arrhythmias, Diabetes Mellitus, Renal Insufficiency
- Trial name
- NCT02148991
- Where
- 2 sites in Greece
- Volunteers
- 100 people
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology.
- Trial name
- NCT07884318
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Aortic Valve Stenosis
Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man
- Trial name
- NCT03779620
- Testing
- Ultrasound treatment of Calcified aortic valve
- Where
- 2 sites in France, Netherlands
- Volunteers
- 30 people
- Sponsor
- Cardiawave SA
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.
Heart Diseases
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators
- Trial name
- NCT00162448
- Testing
- BMS-394136
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Bristol-Myers Squibb
Single Ventricle Heart Disease
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.
- Trial name
- FUEL-2 (NCT05918211)
- Testing
- Udenafil
- Where
- 40 sites in United States, South Korea
- Volunteers
- 436 people
- Sponsor
- Mezzion Pharma Co. Ltd
Pulmonary Arterial Hypertension
A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in…
- Trial name
- ARTISAN (NCT05203510)
- Testing
- Parenteral Treprostinil, Oral Treprostinil
- Where
- 28 sites in United States
- Volunteers
- 52 people
- Sponsor
- United Therapeutics
Advanced Heart Failure
A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure
The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.
- Trial name
- NCT07757451
- Testing
- DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Quantitative Validation for Ventricular SPECT Imaging
Validation of Quantitative Ventricular Function Imaging Single Photon Emission Tomography (Spect)Using the D-SPECT Cardiac Camera
The purpose of this study is to validate the use of DSPECT camera for the performance of quantitative spect ventricular function imaging by comparison to a validated procedure performed on standard nuclear cameras.
- Trial name
- NCT01296737
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Spectrum Dynamics
Healthy Volunteer
Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults
The primary objective of Part 1 of the study is to evaluate the safety and tolerability of S-648414 after administration of a single oral dose of S-648414 in healthy adult study participants.
- Trial name
- NCT04147715
- Testing
- S-648414, Midazolam, Dolutegravir
- Where
- 2 sites in United States, Japan
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shionogi
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
Aortic Stenosis
U.S. Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis undergoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT06069661
- Testing
- Aortic Stenosis
- Where
- United States
- Sponsor
- EnCompass Technologies, Inc.
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
Ischemic Heart Failure
PARACHUTE China Approval Trial
The design of this study is a multi-center, prospective, single-arm clinical trial to evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning system.
- Trial name
- NCT02240940
- Testing
- Parachute Implant
- Where
- 7 sites in China
- Volunteers
- 30 people
- Sponsor
- CardioKinetix, Inc
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Survival Myocardial Area After Acute Myocardial Death, Left Ventricular Ejection Fraction
Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI
In this study, advanced techniques of myocardial nuclear magnetic perfusion scanning were used to quantitatively assess infarct size after acute myocardial infarction, saved viable myocardium, and microcirculatory obstruction…
- Trial name
- NCT03958422
- Testing
- cardiomyopeptidin
- Volunteers
- 160 people
- Sponsor
- Dalian Zhen-Ao Bio-Tech Co., Ltd.
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA