Clinical trials: Heart Valve Prosthesis
Atrial Fibrillation, Atrial Flutter
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Venous Thromboembolic Disease, Myocardial Infarction
- Trial name
- EmbraceAC (NCT00691470)
- Testing
- ATI-5923, Coumadin (warfarin)
- Where
- 41 sites in United States
- Volunteers
- 600 people
- Sponsor
- ARYx Therapeutics
Patients Receiving Animal-derived Bioprosthetic Heart Valves
TRANSLINK: Defining the Role of Xeno-directed and Immune Events (SVD) in Patients Receiving Animal-derived Bioprosthetic Heart Valves
Cardiac valve disorders are widely spread in the general population and represents the third most frequent cardiovascular illness after coronary disease and arterial hypertension.
- Trial name
- TRANSLINK (NCT02023970)
- Testing
- Patients receiving animal-derived bioprosthetic heart valves., Echocardiography (1), Echocardiography (2)
- Where
- 5 sites in Canada, France and 2 more
- Volunteers
- 1,668 people
- Sponsor
- Nantes University Hospital
Endocarditis, Endocarditis;Chronic
64Cu-DOTATATE PET-CT-skanning and Infective Endocarditis.
The investigators hypothesize that the 64Cu-DOTATATE will show uptake in the infected vegetations on the prosthetic heart valves and increase the accuracy of the right diagnosis - thus increasing the sensitivity and specificity…
- Conditions
- Endocarditis, Endocarditis;Chronic, Endocarditis Acute
- Trial name
- NCT05432427
- Testing
- 64Cu-DOTATATE and 18F-FDG
- Where
- Denmark
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Emil Loldrup Fosbol
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
Aortic Valve Stenosis
Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
In Europe TAVI is now recommended for treatment of aortic valve stenosis from the age of 70 years. When performing TAVI in young patients, lifetime management becomes important in terms of anticipated TAVI-in-TAVI procedures when…
- Trial name
- BALANCE (NCT07794306)
- Testing
- Meril Octapro+ THV System, Abbott Navitor/Navitor Vision THV system
- Where
- Germany
- Volunteers
- 510 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation
Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
There is evidence on the role of the phosphotransfer system in the energy metabolism of the heart, with altered energetics playing an important role in the mechanisms of heart failure.
- Trial name
- PRISE (NCT02757443)
- Testing
- Phosphocreatine sodium tetrahydrate after anaesthesia induction, 5% Glucose after anaesthesia induction, Phosphocreatine sodium tetrahydrate added to cardioplegia
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Valve Heart Disease, Anticoagulants; Increased
Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy
Guidelines recommended that patients with bioprosthetic heart valves (BHV) only need 6 months oral anticoagulation therapy after operation.
- Trial name
- REDUCE (NCT03885180)
- Testing
- Warfarin Sodium
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Wuhan Asia Heart Hospital
AORTIC VALVE DISEASES, Aortic Stenosis
Invasive Versus Echocardiography-derived Transvalvular Gradients After TAVI Usign Balloon-expandable Transcatheter Heart Valves.
The aim of this prospective registry is to compare invasive versus echocardiography-derived transvalvular gradients before and after TAVI with balloon-expandable THVs.All patients will undergo a transthoracic echocardiogram in…
- Trial name
- IVEGA-TAVI (NCT06753227)
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- Deutsches Herzzentrum Muenchen
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
Atrial Fibrillation, Venous Thromboembolism
The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register)
Anticoagulants are used to prevent thrombotic events in patients with predisposing factors. However, the use of such therapies is associated with bleeding complications, which can be a serious safety issue.
- Conditions
- Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases or Prosthesis
- Trial name
- START-Portugal (NCT03977363)
- Testing
- Anticoagulant drugs
- Where
- Portugal
- Volunteers
- 25 people
- Sponsor
- CHAD
Aortic Valve Disease
4D- Flow- MRI After Aortic Valve Surgery
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement…
- Trial name
- NCT04223713
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Stenosis
Hydra Registry - Italy Experience
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
- Trial name
- NCT05956652
- Testing
- Hydra Transcatheter Aortic Valve System
- Where
- 4 sites in Italy
- Sponsor
- Sahajanand Medical Technologies Limited
Alternative Surgical Treatment for Aortic Valve Disease
TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St.
- Trial name
- TriRec (NCT03600662)
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 128 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
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
Thrombosis
Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis
Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known.
- Trial name
- NCT02240953
- Testing
- Warfarin, Warfarin + ASA 100 mg + PPI, Warfarin + ASA 300 mg + PPI
- Where
- Turkey (Türkiye)
- Volunteers
- 180 people
- Sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Left Main Coronary Artery Disease, Left Anterior Descending Coronary Artery Stenosis
Prospective Evaluation for Hybrid Cardiac Procedures
Multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream in cardiovascular medicine.
- Conditions
- Left Main Coronary Artery Disease, Left Anterior Descending Coronary Artery Stenosis, Valve Disease, Heart, Carotid Stenosis
- Trial name
- PERHAPS (NCT05143671)
- Testing
- Coronary artery bypass grafting, Percutaneous coronary intervention, Surgical valve replacement
- Where
- Italy
- Volunteers
- 134 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial
A randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis.
- Trial name
- CHOICE (NCT01645202)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- Germany
- Volunteers
- 241 people
- Sponsor
- Segeberger Kliniken GmbH