Clinical trials: Single Ventricle
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.
Congestive Heart Failure
A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
This is a Phase 1, single-center, randomized, double-blind, single ascending dose, placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart failure due to left ventricular systolic dysfunction, to…
- Trial name
- NCT02388464
- Testing
- MTP-131
- Where
- Bulgaria
- Volunteers
- 36 people
- Sponsor
- Stealth BioTherapeutics Inc.
Heart Failure
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.
- Trial name
- GGF2-1101-1 (NCT01258387)
- Testing
- Glial growth factor 2/ Neuregulin 1β3
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Acorda Therapeutics
Cicatrix
Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males
This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged…
- Trial name
- NCT00594581
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Renovo
Aortic Valve Stenosis
Hydra Single-centre Experience - Copenhagen, Denmark
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure.
- Trial name
- NCT06342635
- Testing
- Hydra Transcatheter Aortic Valve (THV) Series
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Sahajanand Medical Technologies Limited
Failure of Fontan Type Circulation, Fenestration
Occlutech AFR Fontan Study
The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation.
- Conditions
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
- Trial name
- NCT07532369
- Testing
- Occlutech Atrial Flow Regulator Retrospective Data Collection
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Occlutech International AB
Aortic Valve Calcification, Aortic Valve Stenosis
VALVOSOFT® Pivotal Study
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
- Trial name
- NCT05235568
- Testing
- VALVOSFT intervention
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Cardiawave SA
Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial…
- Trial name
- AFRVR (NCT07722039)
- Testing
- SMD-RVECG
- Volunteers
- 348 people
- Sponsor
- HUINNO Co., Ltd
Indication for Peripheral Intravenous Catheterization, Atrial Flutter
SHERLOCK 3CG™ Diamond Tip Confirmation System
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally…
- Conditions
- Indication for Peripheral Intravenous Catheterization, Atrial Flutter, Premature Atrial Contraction, Premature Ventricular Contraction
- Trial name
- MODUS II (NCT03288766)
- Testing
- PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
- Where
- 8 sites in United States, Australia
- Volunteers
- 232 people
- Sponsor
- C. R. Bard
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.
Heart Failure, Cardiomyopathy, Hypertrophic
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.
- Conditions
- Heart Failure, Cardiomyopathy, Hypertrophic, Left Ventricular Hypertrophy
- Trial name
- NCT05646056
- Testing
- Software
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Prolaio
Central Nervous System Neoplasms, Glioblastoma
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting…
- Conditions
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma, Adult, Anaplastic Oligodendroglioma
- Trial name
- NCT04541082
- Testing
- ONC206
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Jazz Pharmaceuticals
Advanced Heart Failure
DuoCor 2 DOMINATE Study
Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation.
- Trial name
- NCT07233876
- Testing
- DuoCor Ventricular Assist System
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Heart Failure
MDT-1118 Japan DT Study
To evaluate the safety and effectiveness of the MDT-1118 VAD in a patient population for destination therapy (long term support) of advanced heart failure.
- Trial name
- MDT-1118 Japan (NCT03884504)
- Testing
- Ventricular Assist Device System
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics
The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
- Trial name
- HEARTWORK (NCT01065051)
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Bayer
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 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.
Congenital Heart Disease With Fontan Circulation
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study…
- Trial name
- RUBATO OL (NCT03775421)
- Testing
- macitentan 10 mg
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 112 people
- Sponsor
- Actelion
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
- 10 people
- Sponsor
- EnCompass Technologies, Inc.
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.