Clinical trials: Heart Valve Prosthesis
Aortic Valve Disease, Myocardial Ischemia
Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery
The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a…
- Trial name
- NCT02694016
- Testing
- Remote ischemic preconditioning
- Where
- Finland
- Volunteers
- 4 people
- Sponsor
- Oulu University Hospital
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
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
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
Aortic Valve Stenosis, Aortic Valve Insufficiency
Pilot Trial: Comparison of Flow Patterns
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.
- Trial name
- NCT02288871
- Testing
- Cardiac CT-scan
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Medical University of Vienna
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction
Randomized Evaluation for Failed TAVR
REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention…
- Conditions
- Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure
- Trial name
- REVIVE-TAVR (NCT06400342)
- Testing
- TAVR-explant, Redo-TAVR
- Volunteers
- 264 people
- Sponsor
- Medstar Health Research Institute
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Hypoprothrombinemia
Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin
Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematician Michael Fearon), which…
- Trial name
- NCT02267408
- Testing
- Warfarin adjustment using the Fearon algorithm, Warfarin adjustment using standard dosing
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- McMaster University
Heart Valve Diseases
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality
- Trial name
- NCT04442100
- Testing
- valve prosthetics
- Where
- Russia
- Volunteers
- 500 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Aortic Valve Disease
Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis
Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet HF in the period 1977-87.
- Trial name
- Hall-Kaster (NCT00486928)
- Where
- Norway
- Volunteers
- 816 people
- Sponsor
- Oslo University 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
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
Aortic Valve Disease, Aortic Valve Stenosis
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT06518681
- Testing
- PoliaValve (Aortic)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Aortic Aneurysm, Aortic Dissection
Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement
The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Endocarditis, Root Abscess
- Trial name
- NCT04068337
- Testing
- Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement
- Where
- Switzerland
- Volunteers
- 278 people
- Sponsor
- Triemli Hospital
Aortic Valve Stenosis, Aortic Valve Regurgitation
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
- Trial name
- ECHOCATH (NCT05459233)
- Testing
- Doppler-echocardiography, Invasive hemodynamic measurements
- Where
- 7 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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
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
Kidney Failure, Chronic, Coronary Artery Disease
Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary bypass or valve surgery) in patients with impaired renal function after randomization to either nifedipine infusion at start of surgery…
- Trial name
- NCT00244530
- Testing
- Nifedipine
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- University of Oslo School of Pharmacy