Clinical trials: Valve-in-valve Procedures
Fontan Procedure, Hypoplastic Left Heart Syndrome
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
- Trial name
- NCT00974025
- Testing
- Vitamin C
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
Tetralogy of Fallot, Pulmonary Valve Insufficiency
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood…
- Conditions
- Tetralogy of Fallot, Pulmonary Valve Insufficiency, Ventricular Dysfunction, Right
- Trial name
- NCT00112320
- Testing
- PVR plus RV remodeling, Standard PVR
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Boston Children's Hospital
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle…
- Conditions
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Other Specified Congenital Anomalies of Heart
- Trial name
- TEMPO (NCT01292551)
- Testing
- Bosentan
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 75 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Pediatric Disorder, Hydronephrosis in Children
Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve
To determine the short-term effects of concurrent valve ablation and bladder neck incision on re-intervention rate for patients with posterior urethral valve.
- Conditions
- Pediatric Disorder, Hydronephrosis in Children, Hydronephrosis, Secondary, Hydronephrosis Congenital
- Trial name
- NCT05087537
- Testing
- Valve ablation, Valve ablation and bladder neck incision
- Where
- Egypt
- Volunteers
- 62 people
- Sponsor
- Mansoura University
Fontan Procedure, Hypoplastic Left Heart Syndrome
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Double Inlet Left Ventricle
- Trial name
- NCT01107990
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Valve-in-valve Procedures
TAV-in-SAV in Japanese Patients
Background In 2018, transcatheter aortic valve in surgical aortic valve (TAV-in-SAV) in high risk patients was approved for the treatment of bioprosthetic valve dysfunction due to aging, for which valve replacement had been…
- Trial name
- NCT06826027
- Where
- 10 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Osaka University
Aortic Valve Disease
Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases
Prospective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and paediatric patients.
- Trial name
- NCT04816851
- Testing
- OZAKI technique
- Where
- Egypt
- Volunteers
- 1 people
- Sponsor
- Assiut University
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program.
- Conditions
- Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD), Neurodevelopmental Disorders and Developmental Abnormalities, Developmental Delay (Disorder)
- Trial name
- GEN-HOPE (NCT07493096)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Healing Hope International
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
PROM, Patient Reported Outcomes
Patient Reported Outcomes (PROMs) in Transcatheter Aortic Valve Implantation (TAVI) Patients
The transcatheter Aortic Valve Implantation (TAVI) population with severe aortic stenosis (AS) is characterized by advanced age (most patients are octogenarians) and multiple comorbidities.
- Conditions
- PROM, Patient Reported Outcomes, Transcatheter Aortic Valve Implantation
- Trial name
- NCT05808907
- Testing
- Questionnaire
- Where
- Israel
- Volunteers
- 250 people
- Sponsor
- Rabin Medical Center
Aortic Valve Replacement, Coronary Artery Bypass Grafting
Hemodynamic Assessment of Mosaic Ultra Stented Heart Valve in the Aortic Position
The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows valves to maintain their natural leaflet structure and root geometry which prevents leaflet calcification and improves hemodynamic…
- Trial name
- NCT00477555
- Testing
- Aortic implantation of Mosaic Ultra porcine bioprosthesis
- Where
- 11 sites in Austria, Belgium and 3 more
- Volunteers
- 43 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery
- Trial name
- NCT01107730
- Testing
- Vitamin C, L-Carnitine
- Where
- Greece
- Volunteers
- 33 people
- Sponsor
- Attikon Hospital
Aortic Valve Insufficiency
Results of the Aortic Valve Reconstruction in Children
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system.
- Trial name
- NCT04162444
- Testing
- Physical examination, The Ross Classification for Heart Failure in Children, The Aristotle score
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Irreversible Pulpitis, Reversible Pulpitis
In Vivo Pulp Thermal Changes During Different Slenderization Techniques
The goal of this study is to learn about the temperature rise inside the living part of a tooth (the pulp) during different ways of removing a small amount of enamel (the hard outer layer of the tooth), a procedure called…
- Conditions
- Irreversible Pulpitis, Reversible Pulpitis, Thermal Injury, Pulp Hyperemia
- Trial name
- IPR (NCT07391124)
- Testing
- High-Speed Air-Driven Drill (Airotor and Bur), Orthodontic IPR Kit (Oscillating System)
- Where
- Pakistan
- Volunteers
- 30 people
- Sponsor
- Armed Forces Institute of Dentistry, Pakistan
Tetralogy of Fallot
Follow up of Post-repair Tetralogy of Fallot
Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past five decades, surgical repair has been performed with respectable results. However, relevant postoperative residues frequently remain.
- Trial name
- NCT00266188
- Where
- 14 sites in Germany
- Volunteers
- 406 people
- Sponsor
- Competence Network for Congenital Heart Defects
Mitral Prosthetic Valve Stenosis and Regurgitation
Redo Surgery or Transcatheter Valve-in-Valve for Mitral Bioprosthetic Dysfunction (SURViV)
Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction.
- Trial name
- SURVIV (NCT04402931)
- Testing
- Transcatheter Valve-in-Valve Intervention, Redo Mitral valve surgery
- Where
- 7 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Aortic Valve Stenosis, AV Block
Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry
There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI Prospective, multicenter, European registry in…
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct-pro (NCT03715894)
- Testing
- transcatheter valve implantation
- Where
- 5 sites in Germany, Netherlands and 1 more
- Volunteers
- 300 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Congenital Mitral Insufficiency
Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair
The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients after mitral repair.
- Trial name
- NCT06039592
- Testing
- Captopril Tablets, Metoprolol Oral Tablet, Spironolactone Tablets
- Where
- China
- Volunteers
- 164 people
- Sponsor
- China National Center for Cardiovascular Diseases