Clinical trials: Single Ventricle Heart Disease
Heart Failure, Left Ventricular Dysfunction
Effects of Viagra on Heart Function in Patients With Heart Failure
Sildenafil (Viagra) is known to reduce pulmonary hypertension. Heart failure patients also have pulmonary hypertension and several recent reports have shown that sildenafil leads to an improvement in their exercise capacity.
- Trial name
- NCT00781508
- Testing
- sildenafil
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- MetroHealth Medical Center
Congenital Heart Disease
Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells
The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for individuals with declining performance of their single…
- Trial name
- NCT02549625
- Testing
- Autologous Bone Marrow-derived Mononuclear Cells
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Timothy J Nelson, MD, PhD
Ischemia Coronary Artery Origin
Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery
Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF).
- Trial name
- NCT03719248
- Testing
- thoracic epidural
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ahmed Said Elgebaly,MD
Single-ventricle
Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will…
- Trial name
- NCT05634226
- Testing
- Hands-free oral-positive pressure device (oPEP)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Tarek Alsaied
Atrial Fibrillation, Cardiac Pacing, Artificial
Dual Chamber Versus Single Chamber Cardiac Pacing in People 80 Years of Age and Older
Of the 19,000 pacemakers implanted across Canada in 2002, 1/3 of them were for patients 80 years and older. This is the fastest growing segment of our population, yet no study has specifically been done in this age group to…
- Trial name
- NCT00116987
- Testing
- Dual chamber cardiac pacemaker, Single chamber cardiac pacemaker
- Where
- Canada
- Volunteers
- 800 people
- Sponsor
- University of Calgary
Aortic Valve Stenosis, Heart Valve Diseases
Cardiac Function After Minimally Invasive Aortic Valve Implantation
This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible.
- Trial name
- CMILE (NCT01972555)
- Testing
- Minimally invasive aortic valve replacement, Conventional aortic valve replacement
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Karolinska University Hospital
Aortic Stenosis, Coronary Artery Disease
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis.
- Conditions
- Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis
- Trial name
- COMPLETE TAVR (NCT04634240)
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- 72 sites in United States, Canada
- Volunteers
- 4,000 people
- Sponsor
- University of British Columbia
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
Hypoplastic Left Heart Syndrome, Obstructive Sleep Apnea Syndrome
Sleep Disordered Breathing in Children With Single Ventricle Physiology
This is an exploratory study designed to evaluate the incidence of, and to quantify sleep disordered breathing following stage I Norwood reconstructive surgery. Sleep disordered breathing will be correlated with: 1.
- Conditions
- Hypoplastic Left Heart Syndrome, Obstructive Sleep Apnea Syndrome, Single Ventricle Physiology
- Trial name
- NCT00156455
- Where
- United States
- Sponsor
- University of Rochester
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
Healthy
Japan Central Aortic Pressure Prospective Study
Purpose of the study 1. The predictive value of central aortic pressure and aortic pulse wave velocity (PWV) in a Japanese population is not known.
- Trial name
- J-CARP (NCT01243840)
- Where
- Japan
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Yoshio Matsui
Severe Aortic Valve Disease
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Objectives: This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.
- Trial name
- NCT04696926
- Testing
- Edwards Intuity TM Valve implantation
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Severe Aortic Valve Stenosis, Aortic Valve Stenosis
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully…
- Conditions
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- REAC-TAVI2 (NCT05283356)
- Testing
- Ticagrelor 60mg
- Where
- Spain
- Volunteers
- 1,206 people
- Sponsor
- Fundacin Biomedica Galicia Sur
Severe Aortic Valve Stenosis
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation
The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- POP ATLANTIS (NCT06168370)
- Testing
- CT guided strategy
- Where
- Netherlands
- Volunteers
- 2,500 people
- Sponsor
- St. Antonius Hospital
Failing Fontan Physiology, Failing Fontan
The Destination Therapy Evaluation for Failing Fontan Study
Purpose: The purpose of the Destination Therapy Evaluation for Failing Fontan Study (DEFINe Study) is to perform a single center physician-investigator led feasibility study to initiate examination of the safety and efficacy of…
- Conditions
- Failing Fontan Physiology, Failing Fontan, Single-ventricle, Single-ventricle Fontan
- Trial name
- DEFINe (NCT01149603)
- Testing
- HeartMate II Ventricular Assist Device
- Where
- United States
- Sponsor
- Timothy Icenogle, MD
Heart Failure, Cardiomyopathy, Dilated
Role of Left Ventricular Pacing Site
Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.
- Conditions
- Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
- Trial name
- NCT00221780
- Testing
- left ventricular pacing
- Where
- France
- Volunteers
- 33 people
- Sponsor
- University Hospital, Bordeaux
CHD - Congenital Heart Disease, Single Ventricle Heart Disease
PRecision Integrated Saturation Monitor
The purpose of this study is to find out if an abdominal pulse oximeter device is as accurate as a conventional fingertip pulse oximeter in pediatric patients.
- Trial name
- PRISM (NCT07686341)
- Testing
- vital sign monitoring
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Le Bonheur Children's Hospital
Congenital Disorders
Spironolactone in Patients With Single Ventricle Heart
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions.
- Trial name
- NCT00211081
- Testing
- Spironolactone (drug)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
Hypoplastic Left Heart, Congenital Heart Disease
Cardiac Biomarkers in Patients With Single Ventricle Physiology
All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and…
- Conditions
- Hypoplastic Left Heart, Congenital Heart Disease, Cyanotic Congenital Heart Disease, Cardiac Disease
- Trial name
- NCT03678909
- Testing
- Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Baylor College of Medicine
Heart Defects, Congenital
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on…
- Trial name
- NCT00115934
- Testing
- Blalock-Taussig pulmonary artery shunt, Right ventricular to pulmonary artery shunt
- Where
- 13 sites in United States, Canada
- Volunteers
- 555 people
- Sponsor
- Carelon Research