Clinical trials: Single Ventricle Heart Disease
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.
Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease
PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF
To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease, Stable GDMT
- Trial name
- PCI-GULF (NCT07349979)
- Testing
- Percutaneous coronary intervention, Guideline-directed medical therapy
- Where
- China
- Volunteers
- 1,154 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Coronary Artery Disease
CorVad Percutaneous Ventricular Assist System Study
This study aims to evaluate the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent…
- Trial name
- NCT06198998
- Testing
- CorVad Percutaneous Ventricular Assist System
- Where
- 12 sites in China
- Volunteers
- 120 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Congenital Heart Disease, Single Ventricle
Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training
Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles.
- Conditions
- Congenital Heart Disease, Single Ventricle, Univentricular Heart
- Trial name
- NCT02283255
- Testing
- Aerobic Exercise Training, Inspiratory Muscle Training, No Exercise Training
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)
Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease
This study will evaluate whether adding Yiqi Fumai lyophilized injection to stable guideline-directed treatment improves symptoms, physical limitations, and NT-proBNP in adults with stable chronic heart failure caused by coronary…
- Conditions
- Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Coronary Heart Disease (CHD)
- Trial name
- NCT07803471
- Testing
- Yiqi Fumai Lyophilized Injection(YQFM), Stable Guideline-Directed Medical Therapy
- Where
- 4 sites in China
- Volunteers
- 100 people
- Sponsor
- China Academy of Chinese Medical Sciences
Aortic Valve Stenosis, Aortic Stenosis
Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Valve Stenoses, Aortic, Aortic Valve Calcification
- Trial name
- NCT04056832
- Testing
- Single Strip Pericardium, Mechanical Prosthetic Valve
- Where
- Indonesia
- Volunteers
- 62 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Heart Failure, Aortic Stenosis, Severe
Effects of Levosimendan on Cardiac Function After TAVR in Patients With Heart Failure
Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of transcatheter aortic valve…
- Trial name
- NCT06196177
- Testing
- Levosimontane injection
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Qilu Hospital of Shandong University
Heart Failure, Left Bundle-Branch Block
LV Only MPP With SyncAV
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy…
- Trial name
- NCT03567096
- Testing
- BiV pacing with MPP and SyncAV, LV only pacing with MPP and SyncAV
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Coronary Arterial Disease
Effect of Dapagliflozin on Right Ventricular-Pulmonary Artery Coupling After Off-Pump Coronary Atery Bypass Grafting
This prospective, single-center observational study evaluates the effect of dapagliflozin 10 mg/day on right ventricular-pulmonary artery coupling measured by the TAPSE/PASP ratio in 72 patients with left ventricular ejection…
- Trial name
- DAPA-RV-CABG (NCT07601867)
- Where
- Russia
- Volunteers
- 72 people
- Sponsor
- Pyatigorsk City Clinical Hospital Number 1
Left Ventricular Diastolic Dysfunction, Hyperlipidemias
Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia
preserved left ventricular ejection fraction (LVEF ≥ 50%) and are accompanied by dyslipidemia (LDL ≥ 100 mg / dl) will be enrolled. Only patients who do not meet the exclusion criteria should be enrolled in the study.
- Trial name
- NCT04433533
- Testing
- Rosuvastatin 20, Rosuvamibe 10/10
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Yonsei University
Heart Failure
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic…
- Trial name
- ARTS-HF (NCT01807221)
- Testing
- Finerenone (BAY94-8862), Inspra (eplerenone)
- Where
- 172 sites in United States, Australia and 23 more
- Volunteers
- 1,066 people
- Sponsor
- Bayer
Aortic Valve Stenosis, Coronary Artery Disease
Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR
The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after…
- Trial name
- FORTUNA (NCT03665389)
- Testing
- iFR / FFR measurement
- Volunteers
- 25 people
- Sponsor
- Kobe University
Left Ventricular Dysfunction, Ventricular Dysfunction
Low Ejection Fraction in Single Lead ECG
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
- NCT05010655
- Testing
- Use of Eko DUO Electronic Stethoscope
- Where
- 2 sites in United States
- Volunteers
- 1,935 people, healthy volunteers welcome
- Sponsor
- Eko Devices, Inc.
Hypoplastic Left Heart Syndrome
Positive Pressure Ventilation and Sternal Closure in HLHS
This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure.
- Trial name
- NCT02455713
- Testing
- PEEP and PIP
- Where
- Canada
- Sponsor
- The Hospital for Sick Children
AORTIC VALVE DISEASES, Aortic Valve Stenosis
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT07123766
- Testing
- PoliaValve (Aortic)
- Volunteers
- 50 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Congenital Heart Disease, Single Ventricle
Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training
Mechanisms that typically result in increased cardiac output, such as inotropic support, increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation.
- Trial name
- NCT01977222
- Testing
- THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Boston Children's Hospital
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.
Congenital Disorders
Intra-Atrial vs. Extra-Cardiac Technique During Fontan Operation
Our aim is a retrospective chart review seeking to determine any differences in the main clinical and outcome variables as well as general outcome data such as functional recovery, readmission rates, somatic growth and mortality.
- Trial name
- NCT00266942
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Children's Healthcare of Atlanta
Aortic Stenosis, Severe, Aortic Valve Stenosis
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation (TAVI) procedure can be used…
- Trial name
- CONTINUUM-CT (NCT06596460)
- Testing
- TAVI planning CT (adapted)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Barts & The London NHS Trust
Severe Aortic Stenosis
A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis
Trial Title: Prospective, multicenter, single-arm target value clinical trial to evaluate the safety and efficacy of a transcatheter aortic valve system in the treatment of patients with severe aortic stenosis Test device…
- Trial name
- NCT06136429
- Testing
- Transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Pan Xiangbin