Clinical trials: Prosthetic Heart Valve
Para-prosthetic Heart
Para-Prosthetic Valve Leak Closure Observatory - PVLC2
Para-prosthetic heart valve leakage is an evolving complication after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.
- Trial name
- FFPP2 (NCT07049991)
- Testing
- surgical or percutaneous heart valve replacement.
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Mitral Valve Disease, Damaged Mitral Valve
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially…
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Trial name
- NCT02097420
- Testing
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Where
- 24 sites in United States
- Volunteers
- 23 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Mitral Valve Disease
Artificial Valve Endocarditis Reduction Trial
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Trial name
- AVERT (NCT00590889)
- Testing
- Artificial Mechanical Heart Valve
- Where
- 16 sites in United States, Canada and 6 more
- Volunteers
- 807 people
- Sponsor
- Abbott Medical Devices
Pregnancy, Anticoagulation
Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves
The ability to diagnose and surgically repair poorly functioning heart valves has yielded a significant population of women that are of childbearing age with mechanical/ bioprosthetic heart valves.
- Conditions
- Pregnancy, Anticoagulation, Prosthetic Heart Valves
- Trial name
- NCT00329290
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, Irvine
Prosthetic Valve Thrombosis
A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots
The optimal dosage and duration of administration of clot-dissolving medications for the treatment of patients with mechanical heart valves with clots is not known.
- Trial name
- RAFT-PVT (NCT00232622)
- Testing
- Streptokinase
- Volunteers
- 120 people
- Sponsor
- All India Institute of Medical Sciences
Poor Drug Response
The Prevalence of Sub Optimal Anti Coagulation
A study on warfarin administration to show whether noncompliance of the patient will affect our target (INR) during therapy or not beside its drug and dietary interactions.
- Trial name
- NCT03485300
- Testing
- Liver and kidney function tests for patients with chronic liver or kidney diseases, Non compliance of the patient, Drug or food interactions
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Assiut University
Heart Valve Prosthesis
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.
- Trial name
- NCT05986396
- Testing
- INSPIRIS Resilia (model 11500A)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor College of Medicine
Mycobacterium Chimaera Infections
Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices. So far optimal therapeutical concepts are not clear.
- Trial name
- NCT04429256
- Testing
- data collection
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- University Hospital, Basel, Switzerland
Heart Valve Stenosis
ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
- Trial name
- NCT01264484
- Testing
- Advantage Prosthetic Heart Valve
- Where
- 2 sites in Germany
- Volunteers
- 212 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Severe Aortic Valve Stenosis
In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.
- Trial name
- SurPASS (NCT06859255)
- Testing
- MRI
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Policlinico S. Donato
Maternal Complications After Oral Anticoagulation When Initiated Early and Late After Caesarean Section Done for Patients With Mechanical Heart Valve Prosthesis
Early Versus Late Post Caesarean Section Oral Anticoagulation Initiation and Risk of Maternal Complications in Patients With Mechanical Heart Valve Prosthesis
A randomized cohort study applied to patients with mechanical heart valve prosthesis who will be delivered by caesarean section at or after 28 weeks of gestation .
- Trial name
- NCT04855110
- Testing
- Warfarin Sodium started on Day 2 after caesarean section (in a dose that achieves a therapeutic level as indicated by the cardiology consultant), Warfarin Sodium started on day 5 after caesarean section (in a dose that achieves a therapeutic level as indicated by the cardiology consultant)
- Where
- Egypt
- Volunteers
- 114 people
- Sponsor
- Cairo University
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Supra-Annular vs. Annular ValvEs for Small Annuli
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
- Trial name
- SAVE (NCT04372381)
- Testing
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Where
- 3 sites in United States
- Sponsor
- University of Arizona
Complications Due to Heart Valve Prosthesis
Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis
The combined Antiplatelet and Anticoagulant treatment decreased thrombus formation and overall mortality. Also the initiation of an efficacious early anticoagulation protocol is important because of its potential impact on the…
- Trial name
- HVP (NCT02022527)
- Testing
- Acetyl Salicylic Acid, Warfarin
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Pharmacoeconomic Unit, Egypt
Heart Valve Prosthesis
Individualized Administration of Warfarin by Polymorphisms of VKORC1 and CYP2C9 Genes
The purpose of this study is to explore the individualized administration model of warfarin suitable for Chinese people, and provide a scientific reference for the use of warfarin to Chinese people.
- Trial name
- NCT03797534
- Testing
- dose regime
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Fujian Medical University
Aortic Valve Disease
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease.
- Trial name
- NCT06011148
- Testing
- Perceval S sutureless heart valve
- Volunteers
- 80 people
- Sponsor
- Corcym S.r.l
Aortic Valve Disease
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15…
- Trial name
- NCT03924661
- Testing
- Aortic Valve Replacement
- Where
- 13 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices