Clinical trials: Single Ventricle Heart Disease
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Safety and Efficacy of Emergent TAVI in Patients With Severe AS
This is a single-centre, prospective, observational cohort study focusing on of patients suffering severe aortic valve stenosis (AS) undergoing emergent transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Emergencies
- Trial name
- NCT05528211
- Volunteers
- 10 people
- Sponsor
- Qilu Hospital of Shandong University
Ventricular Tachycardia
Efficacy and Safety of Multisite Cardiac Resynchronization Therapy
Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left ventricular (LV) dysfunction with ejection fraction (EF)<35%., moderate to severe congestive heart failure and wide QRS in ECG.
- Trial name
- NCT01966016
- Testing
- Pacing
- Where
- Israel
- Volunteers
- 11 people
- Sponsor
- Barzilai Medical Center
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 Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Heart Defects, Congenital, Anxiety in Pregnancy
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a…
- Conditions
- Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum, Trauma, Psychological
- Trial name
- HeartGPS (NCT06175104)
- Testing
- HeartGPS
- Where
- 4 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Heart Failure, Ventricular Dysfunction
Effects of Nesiritide in Pediatric Patients With Heart Failure
Children with severe heart failure need immediate appropriate care. New and better drugs are constantly being developed. As these drugs are approved for adult use, they are used off-label for children.
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Decompensation
- Trial name
- NCT00166010
- Testing
- Nesiritide
- Sponsor
- Emory University
Hypoplastic Left Heart Syndrome
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with…
- Trial name
- NCT03779711
- Testing
- Autologous (self) mononuclear cells derived from umbilical cord blood, Stage II Surgical repair
- Where
- 8 sites in United States
- Volunteers
- 95 people
- Sponsor
- Timothy J Nelson, MD, PhD
Heart Disease
Sildenafil in Single Ventricle Patients
Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance.
- Trial name
- NCT01169519
- Testing
- Sildenafil by injection
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Duke University
Left Ventricular Dysfunction
Detection of Heart Conditions With Single Lead ECG Using Artificial Intelligence
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…
- Trial name
- DAVID1 (NCT04400435)
- Testing
- Use of Eko DUO electronic stethoscope
- Where
- 3 sites in United States
- Volunteers
- 1,258 people
- Sponsor
- Eko Devices, Inc.
Ventricular Tachycardia
Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions
This is a research study that aims to understand if giving a lower dose of treatment all at once is as effective and safe as dividing it into three smaller doses for patients with a heart condition called refractory ventricular…
- Trial name
- NCT06743789
- Testing
- Radiation Therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Weill Medical College of Cornell University
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Aortic Stenosis
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 underdoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT05866640
- Testing
- F2 filter and delivery system
- Where
- Georgia
- Volunteers
- 31 people
- Sponsor
- EnCompass Technologies, Inc.
Coronary Artery Disease (CAD)
Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction
Based on a multi-center randomized controlled study, this research aims to evaluate the efficacy and safety of interventional therapy supported by the CorVad percutaneous left ventricular assist system (Micro-axial Flow Pump） for…
- Trial name
- PIVOT (NCT07678021)
- Testing
- Microaxial pump-supported PCI, Optimal medical therapy (OMT)
- Where
- China
- Volunteers
- 452 people
- Sponsor
- China National Center for Cardiovascular Diseases
Pulmonary Embolism, Right Ventricular Dysfunction
Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE
SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2…
- Conditions
- Pulmonary Embolism, Right Ventricular Dysfunction, Right Ventricular Failure
- Trial name
- SONIC-PE (NCT06310018)
- Testing
- Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis, Tissue Plasminogen Activator
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Cirrhotic Cardiomyopathy, Left Ventricular Dysfunction
Ivabradine in Cirrhotic Cardiomyopathy
A total of 130 patients with liver cirrhosis who fulfill the criteria of the study, and who have been found to have left ventricular diastolic dysfunction on a screening 2D echocardiography, will then be randomized by Block…
- Conditions
- Cirrhotic Cardiomyopathy, Left Ventricular Dysfunction, Cirrhosis, Liver, Portal Hypertension
- Trial name
- NCT04111133
- Testing
- Betablocker + ivabradine, Betablocker
- Where
- India
- Volunteers
- 130 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Fontan Physiology, Frailty
WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of…
- Conditions
- Fontan Physiology, Frailty, Single Ventricle Heart Disease
- Trial name
- NCT05199857
- Testing
- WE BEAT Group Wellness Education program - phase 1, HEART Club Home Exercise program - phase 2
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan
Ventricular Tachycardia, Sudden Cardiac Death
Functional Substrate-Only Guided VT Ablation
Ventricular tachycardia (VT) is a leading cause of death and suffering in the Veteran population. Currently, ablation procedures are performed to destroy the diseased tissue that causes this problem.
- Trial name
- SLO-VT (NCT06464315)
- Testing
- Functional Substrate-Only Mapping without VT Induction, Standard-of-Care Mapping/Imaging
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- VA Office of Research and Development
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
Congenital Heart Disease
Endothelin Blockade in Patients With Single Ventricle Physiology
Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar…
- Trial name
- NCT00989911
- Testing
- Bosentan
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, Los Angeles
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences