Clinical trials: Single Ventricle Heart Disease
Single-ventricle
Re-Energize Fontan
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high.
- Trial name
- NCT04195451
- Testing
- Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Stanford University
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
Heart Failure
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
This study is researching an experimental drug called REGN5381, further referred to as study drug. The study is focused on adult participants with heart failure that, in the opinion of the study doctor, have a clinical indication…
- Trial name
- NCT05353166
- Testing
- REGN5381
- Where
- Moldova
- Volunteers
- 59 people
- Sponsor
- Regeneron Pharmaceuticals
Hypertension, Heart Failure
Pulse Wave Parameters in the Assessment of Systolic Function of the Left Ventricle.
This is a prospective, single-center, non-randomized, observational study. The aim of this study is to determine the potential of a single-lead electrocardiogram monitor CardioQvark with photoplethysmography function use to…
- Trial name
- NCT04788342
- Testing
- pulse wave recording, echocardiography.
- Where
- Russia
- Volunteers
- 400 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Congenital Heart Disease
Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT
This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.
- Trial name
- T4G RCT (NCT04702373)
- Testing
- passive range of motion exercise therapy
- Where
- 10 sites in United States, Canada
- Volunteers
- 144 people
- Sponsor
- Carelon Research
Premature Ventricular Contractions
Use of MIBG Scan Images in PVC Ablations
The purpose of this study is to assess if Single Photon Emission Computed Tomography (SPECT) demonstrating cardiac innervation can be integrated into current electrophysiology voltage mapping system and provide improved guidance…
- Trial name
- PVC-MIBG (NCT02279030)
- Testing
- MIBG nuclear scan
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Cardiogenic Shock
Safety and Efficacy of the Extracorporeal Ventricular Assist System in Car Diogenic Shock: A Prospective, Multicenter , Single-Arm Study
Study Title: Safety and Efficacy of Extracorporeal Ventricular Assist System for Cardiogenic Shock: A Prospective, Multicenter, Single-Arm Clinical Study Objective: To evaluate the safety and efficacy of temporary mechanical…
- Trial name
- NCT07769528
- Testing
- EVAS Treatment
- Where
- China
- Volunteers
- 40 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Stenosis
Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06652841
- Testing
- transShield Embolic Protection System
- Where
- New Zealand
- Volunteers
- 2 people
- Sponsor
- TransAortic Medical, Inc.
Aortic Valve Stenosis
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
- Trial name
- NCT04893603
- Testing
- Transcatheter Aortic Valve System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chengdu Silara Meditech Inc.
Altitude Hypoxia, Hypoxia
Effect of Acute Hypoxia on RIght VEntRicular Function in HAPE.
More and more people are engaging in sports in the mountains, including individuals with heart or lung diseases. At the same time, such diseases are becoming more common in Switzerland.
- Conditions
- Altitude Hypoxia, Hypoxia, Normobaric Hypoxia, Right Ventricular Function
- Trial name
- RIVER-HAPE (NCT07431554)
- Testing
- Normobaric Hypoxia
- Where
- Switzerland
- Volunteers
- 18 people
- Sponsor
- Mona Lichtblau
Aortic Stenosis, Aortic Insufficiency
CardioCel Tri-leaflet Repair Study
This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.
- Trial name
- CTRS (NCT02629328)
- Testing
- CardioCel
- Where
- Belgium
- Volunteers
- 28 people
- Sponsor
- Anteris Technologies Ltd.
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
Single-ventricle, Congenital Heart Disease
Fontan Imaging Biomarkers (FIB) Study
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
- Trial name
- FIB (NCT03119090)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Children's Hospital
Single-ventricle
Fibrosis and the Fontan
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics.
- Trial name
- NCT04901975
- Testing
- Spironolactone
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Heart Disease, Single-ventricle
Clinical Characteristics and Associations of the "Good Fontan" Patient
This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse…
- Trial name
- NCT03470428
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Boston Children's Hospital
Arrhythmias, Cardiac, Bradycardia
Analysis of the Efficacy and Stability of a Wearable ECG Monitor
This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a…
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Tachycardia, Atrial Fibrillation
- Trial name
- NCT06546046
- Testing
- ECG monitoring by telemetry device and patch-type ECG monitor at the same time
- Volunteers
- 100 people
- Sponsor
- Mezoo Co., Ltd.
Catecholaminergic Polymorphic Ventricular Tachycardia
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
This is a Phase 1b, Multicenter, Open-Label, Dose Finding Study to Investigate the Safety and Tolerability of a Single Intravenous Dose of SGT-501 in participants with catecholaminergic polymorphic ventricular tachycardia (CPVT).
- Trial name
- ARTEMIS (NCT07148089)
- Testing
- SGT-501
- Where
- 5 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Solid Biosciences Inc.
Heart Failure Low Output
LBBP + CSP Versus LBBP Alone for Cardiac Resynchronization Therapy
The purpose of this pilot clinical trial is to evaluate whether a novel cardiac resynchronization strategy, called LOT-CRT, is more effective than standard physiological pacing alone (LBBAP) in patients with heart failure.
- Trial name
- LOTTO-CRT (NCT07664189)
- Testing
- Left Bundle Branch Optimized CRT, Stimulation of the left bundle branch area (LBBAP)
- Where
- Colombia
- Volunteers
- 10 people
- Sponsor
- Clinica Cardio VID
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical…
- Trial name
- NCT04744857
- Testing
- The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates…
- Conditions
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect, Stress, Psychological
- Trial name
- NCT02462434
- Testing
- Early palliative care team consultation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan