Clinical trials: Mechanical Heart Valve Prosthesis
Mechanical Prosthetic Heart Valve Implantation, Patient Self Monitoring of Oral Anticoagulent Therapy
Benefit of Self-monitoring of Anticoagulation Instrument
To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
- Trial name
- 4A (NCT00506870)
- Testing
- INRatio / Coaguchek XS
- Where
- France
- Volunteers
- 919 people
- Sponsor
- University Hospital, Bordeaux
Heart Failure, Heart Valve Prosthesis
Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prosthetic Heart Valves
This study evaluates whether adding a medication called semaglutide to an existing treatment of dapagliflozin provides better outcomes for patients with heart failure who have previously undergone surgical heart valve…
- Trial name
- SYNCARDIA-HF (NCT07610174)
- Testing
- semaglutide, Dapagliflozin (10mg Tab)
- Where
- Egypt
- Volunteers
- 160 people
- Sponsor
- Kafrelsheikh University
Mechanical Heart Valve Prosthesis
Noise Associated With a Mechanical Heart Valve Prosthesis: Does the Memory of Preoperative Information Have an Influence on Postoperative Quality of Life?
As part of the follow-up in the Day Hospital in the national reference center for Marfan syndrome and related disorders, each consultant benefits from a psychological interview.
- Trial name
- QUALICLIC (NCT07304115)
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Anticoagulation in Pregnancy
Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy
A prospective, randomized, longitudinal, open label, parallel group clinical trial was designed to compare the proportions of failure to reach INR target 2.5-3.5 with either: small dose warfarin (<5 mg/day) or phenindione (<100…
- Trial name
- NCT01758640
- Testing
- Warfarin, phenindione
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Yasser Elnahas
Valvular Heart Disease Patients
Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves
Warfarin is the standard anticoagulant used for patients with mechanical heart valves; however, its use is complicated by a narrow therapeutic window, frequent drug and dietary interactions, and the need for regular international…
- Trial name
- NCT07456085
- Testing
- Rivoroxaban, Warfarin
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Rawalpindi Institute of Cardiology
Rheumatic Heart Disease
Vitamin K Antagonist in Rheumatic Heart Disease Patients With Mechanical Heart Valves: Our Current Status
VKA in RHD patients with MHV: our current status
- Trial name
- VKA and RHD (NCT07146282)
- Volunteers
- 165 people
- Sponsor
- Ahmed Hassan Rostom Ibrahim
Cerebral Hemorrhage
Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves
The investigators retrospectively reviewed the electronic medical records of the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university…
- Trial name
- NCT04450446
- Testing
- Low molecular weight heparin
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Heart Valve Disease
Prospective Randomized On-X Versus SJM Evaluation Trial
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
- Trial name
- PROSE (NCT00639782)
- Testing
- On-X Heart valve replacement, SJM Heart valve replacement
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 857 people
- Sponsor
- On-X Life Technologies, Inc.
Atrial Fibrillation, Deep Vein Thrombosis
Randomized Trial of Interventions to Improve Warfarin Adherence
The purpose of this research study is to see if a lottery which provides the opportunity to win money, a reminder system using a "Med-eMonitor", or the combination of both might be useful in helping patients to achieve better…
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Dilated Cardiomyopathies
- Trial name
- WIN3 (NCT00904982)
- Testing
- Financial Incentive and Med-eMonitor, 2Med-eMonitor
- Where
- 2 sites in United States
- Volunteers
- 268 people
- Sponsor
- University of Pennsylvania
Diseases of Mitral and Aortic Valves, Rheumatic Disorders of Mitral and Aortic Valves
Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease
Acquired heart diseases continue to remain one of the most common causes of cardiac mortality and morbidity. In the Russian Federation, open surgery treatment of acquired valvular heart diseases (AVHD) is performed in more than…
- Conditions
- Diseases of Mitral and Aortic Valves, Rheumatic Disorders of Mitral and Aortic Valves, Other Congenital Malformations of Aortic and Mitral Valves, Valvular Heart Disease (Aortic and Mitral Valves)
- Trial name
- NCT05895487
- Where
- Russia
- Volunteers
- 2,000 people
- Sponsor
- Closed Joint-Stock Company NeoCor
Thromboembolism, Heart Valve Prosthesis
Follow on Study From RE-ALIGN
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
- Trial name
- NCT01505881
- Testing
- dabigatran etexilate low dose, warfarin 5mg, dabigatran etexilate intermediate dose
- Where
- 30 sites in Belgium, Canada and 7 more
- Volunteers
- 158 people
- Sponsor
- Boehringer Ingelheim
Heart Valve Diseases
Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life
The purpose of this study is to compare the sound pressure levels (SPLs) from three of the most frequently implanted mechanical heart valve prostheses, in order to determine whether there was any significant difference between…
- Trial name
- NCT00362401
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- University of Aarhus
Pregnancy, Heart; Complications, Valve, Prosthesis
Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves
Pregnancy is associated with increased risk of thrombosis among women with mechanical prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant patients with prosthetic heart valves have been…
- Trial name
- NCT02240927
- Testing
- Low Molecular Weight Heparine : Enoxaparine, Enoxaparine and 2.5 mg Warfarin, Enoxaparine and 4mg Warfarin
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Atrial Fibrillation, Venous Thromboses
Pharmacogenetic Dosage Algorithm for Acenocoumarol
The use of coumarins has been a challenge for doctors because of its narrow therapeutic range and they show great inter and intra-individual variability in the dose necessary to achieve an international normalized ratio (INR)…
- Conditions
- Atrial Fibrillation, Venous Thromboses, Cardiac Valve Disease
- Trial name
- NCT03015025
- Testing
- Acenocoumarol
- Where
- Spain
- Volunteers
- 340 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Atrial Fibrillation, Deep Venous Thrombosis
Testing Strategies to Improving Warfarin Adherence
We are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin.
- Conditions
- Atrial Fibrillation, Deep Venous Thrombosis, Dilated Cardiomyopathies
- Trial name
- NCT00622102
- Testing
- Lottery arm (Lottery and Med-eMonitor), Non-Lottery (Med-eMonitor only)
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- University of Pennsylvania
Aortic Valve Disease, Artificial Heart Valves
Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with or without concomitant procedures.
- Trial name
- TiAra (NCT05998694)
- Where
- Russia
- Volunteers
- 2,000 people
- Sponsor
- Closed Joint-Stock Company NeoCor
Pregnancy, Prosthetic Heart Valve
Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves
The purpose of this pilot study is to collect data on pregnancies with mechanical heart valves to see if using a blood thinner called low molecular weight heparin (LMWH) and low dose aspirin (LDA) is comparable to…
- Conditions
- Pregnancy, Prosthetic Heart Valve, Anticoagulant Therapy
- Trial name
- NCT07658989
- Testing
- LMWH and LDA, Vitamin K antagonists (e.g warfarin)+/- LDA, Sequential therapy +/- LDA
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- Mount Sinai Hospital, Canada
Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Rivaroxaban in Mechanical Valves: RMV Study
Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients with atrial fibrillation or prosthetic heart valve and the incidence of death and recurrences in patients with VTE.
- Trial name
- RMV (NCT02894307)
- Testing
- Rivaroxaban
- Sponsor
- Hospital Ana Nery
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