Clinical trials: Heart Valve Prosthesis
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, 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
Aortic Valve Stenosis
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.
- Trial name
- SAFETAVR (NCT03600935)
- Testing
- Vancouver Clinical Pathway
- Volunteers
- 315 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Aortic Valve Stenosis
Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.
- Trial name
- NCT03667248
- Testing
- Sorin Perceval ® Sutureless Valve (Sorin Group Italia Srl, 13040 Saluggia, Italy), available in different sizes (S 19-21mm, M 21-23mm, L 23-25mm, XL 25-27mm)
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- University Hospital, Basel, Switzerland
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
Aortic Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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
Eisenmenger Syndrome
Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves
A growing body of data, suggests that transcatheter valves are effective when implanted in other locations (mitral, aortic, tricuspid) and in high pressure environments.
- Trial name
- NCT02119442
- Testing
- Transcather Valve Implantation
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University of California, Los Angeles
Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis
Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy.
This randomized controlled trial aims to compare early postoperative outcomes between Minimally Invasive Valve Surgery (MIVS) via right thoracotomy and Conventional Valve Surgery via median sternotomy in patients undergoing…
- Conditions
- Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis, Aortic Valve Insufficiency, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)
- Trial name
- NCT07251660
- Testing
- Minimally Invasive Valve Surgery, Conventional Valve Surgery
- Volunteers
- 32 people
- Sponsor
- Chaudhry Pervaiz Elahi Institute of Cardiology
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
Heart Valve Diseases, Surgery
Individualised Follow-up After Valve Surgery
This study aims to investigate the effect of an intervention consisting of early, individualised outpatient follow-up after heart valve surgery on unplanned readmissions and death within 180-days after discharge.
- Conditions
- Heart Valve Diseases, Surgery, Readmission
- Trial name
- INVOLVE (NCT03053778)
- Testing
- Early follow-up
- Where
- Denmark
- Volunteers
- 1,414 people
- Sponsor
- Odense University Hospital
Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries. The main questions it aims to answer are: 1.
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment
- Trial name
- NCT06896227
- Testing
- transthoracic echocardiography
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
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 Stenosis, Coronary Artery Disease
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
With the upcoming expansion of transcatheter aortic valve replacement (TAVR) indications to younger patients, the feasibility of coronary ostia cannulation beyond different bioprosthesis stent is currently a matter of debate.
- Trial name
- RE-ACCESS (NCT04026204)
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University of Catania
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
Tetralogy of Fallot, Ventricular Tachycardia
Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot
Individuals with repaired Tetralogy of Fallot (rTOF) remain at risk for sudden cardiac death from ventricular tachycardia (VT). Transcatheter pulmonary valve replacement (TPVR) indications continue to broaden, yet its capability…
- Conditions
- Tetralogy of Fallot, Ventricular Tachycardia, Sudden Cardiac Death
- Trial name
- NCT05236153
- Testing
- Electroanatomic substrate mapping
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Children's Hospital
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
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
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 Stenosis
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals.
- Trial name
- NCT04810195
- Testing
- Boston Scientific Acurate neo2 TAVR device
- Where
- 4 sites in Denmark, Germany and 1 more
- Volunteers
- 554 people
- Sponsor
- Andreas Rück