Clinical trials: Single Ventricle Heart Disease
Cardiogenic Shock
Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the…
- Trial name
- COURAGE (NCT07560085)
- Testing
- SynFlow Duro
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- ForQaly Medical (Shanghai) Co., Ltd
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.
Hypertension, Pulmonary, Ventricular Dysfunction, Left
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
- Trial name
- DILATE (NCT01172756)
- Testing
- Riociguat (BAY63-2521)
- Where
- 7 sites in Austria, Czechia and 1 more
- Volunteers
- 39 people
- Sponsor
- Bayer
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORELLO (NCT07192952)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 132 sites in United States, Argentina and 21 more
- Volunteers
- 117 people
- Sponsor
- Bayer
Aortic Valve Stenosis
The Leaflex™ Early Feasibility Study
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
- Trial name
- NCT04636073
- Testing
- Leaflex™ Performer
- Sponsor
- Pi-cardia
Functional Single Ventricle Heart Disease
A Extension Study of Udenafil in Adolescents
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart…
- Trial name
- FUELExten (NCT03013751)
- Testing
- Udenafil
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Mezzion Pharma Co. Ltd
Left Ventricular Dysfunction, Ventricular Dysfunction
Low Ejection Fraction in Single Lead ECG- Ochsner
The purpose of this research is to prospectively test and validate the single-lead Low EF algorithm in outpatients in order to test the performance of a single-lead ECG based algorithm to identify people with decreased left…
- Conditions
- Left Ventricular Dysfunction, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT05010642
- Testing
- Use of Eko DUO electronic Stethoscope
- Where
- United States
- Volunteers
- 307 people, healthy volunteers welcome
- Sponsor
- Eko Devices, Inc.
Chronic Obstructive Pulmonary Disease, COPD
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
This mechanistic study is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and lung function parameters in hyperinflated COPD…
- Trial name
- CLAIM (NCT02442206)
- Testing
- QVA149
- Where
- Germany
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Valve Stenosis
Valvosoft First-In-Human 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-Human
- Trial name
- NCT04665596
- Testing
- Ultrasound treatment
- Where
- Serbia
- Volunteers
- 10 people
- Sponsor
- Cardiawave SA
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the…
- Trial name
- NCT00583661
- Testing
- EXCOR Pediatric
- Where
- 17 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Berlin Heart, Inc
Heart Failure
Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy.
- Trial name
- CONFIGURE-HF (NCT01568138)
- Testing
- PliCath HF System
- Where
- 4 sites in Latvia, Lithuania and 2 more
- Volunteers
- 26 people
- Sponsor
- BioVentrix
Healthy Chinese Subjects
A Study of Etripamil in Healthy Subjects
The objectives of the study are as below: Primary: ·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects Secondary: To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese…
- Trial name
- NCT05511870
- Testing
- Etripamil Nasal Spray 70mg
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals
Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Trial name
- NCT03110861
- Testing
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Where
- 5 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Taewoong Medical Co., Ltd.
Aortic Stenosis
VitaFlow™ II 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™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04414878
- Testing
- VitaFlow™ II Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 145 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
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
Aortic Stenosis
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
To evaluate the safety and effectiveness of the TaurusNXT™ transcatheter aortic valve system in a patient population with symptomatic severe AS requiring replacement/repair of their native aortic valve that are at high risk for…
- Trial name
- NCT07908225
- Testing
- TAVR
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
- Trial name
- CAP (NCT01242891)
- Testing
- EXCOR® Pediatric Ventricular Assist Device
- Sponsor
- Berlin Heart, Inc
Paroxysmal Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia
A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia
The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter
- Conditions
- Paroxysmal Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia, Atrioventricular Reciprocating Tachycardia
- Trial name
- PSVT (NCT05820035)
- Testing
- Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Shanghai MicroPort EP MedTech 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