Clinical trials: Valve Replacement
Aortic Valve Surgery
Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry
The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.
- Trial name
- SATURNO (NCT02278666)
- Testing
- aortic valve replacement, biological prosthetic valve, Mechanical valve
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Maria Cecilia Hospital
Mitral Valve Regurgitation
Mitral Valve Replacement With MValve Dock and Lotus
This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.
- Trial name
- DOCK 1 (NCT02719912)
- Testing
- mitral valve replacement
- Where
- 4 sites in Brazil, France and 2 more
- Volunteers
- 30 people
- Sponsor
- MValve Technologies Ltd
Diastolic Dysfunction, Left Ventricular Hypertrophy
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of…
- Trial name
- NCT01188369
- Testing
- levosimendan
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- University of Aarhus
Functional Tricuspid Regurgitation
Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation
Aim of the study is to investigate the prognostic value of right ventricular contractile reserve in patients with functional tricuspid regurgitation undergoing tricuspid valve repair or replacement.
- Trial name
- RESERVE (NCT04141683)
- Testing
- Stress Echocardiography, Pressure volume loop analysis, Tricuspid valve repair or replacement
- Where
- Germany
- Volunteers
- 108 people
- Sponsor
- Heart Center Leipzig - University Hospital
Aortic Stenosis, Brain Infarction
Neuroprotection in Patients Undergoing Aortic Valve Replacement
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
- Conditions
- Aortic Stenosis, Brain Infarction, Cerebrovascular Accident, Stroke
- Trial name
- NCT02389894
- Testing
- Embol-X Embolic Protection Device, CardioGard Cannula
- Where
- 18 sites in United States, Canada
- Volunteers
- 383 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Aortic Valve Stenosis, Heart Valve Diseases
First in Man Study of the JenaValve TAVI Plus System Transfemoral
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- CP-0001 (NCT02818959)
- Testing
- JenaValve Pericardial TAVR System
- Where
- 2 sites in Germany
- Volunteers
- 7 people
- Sponsor
- JenaValve Technology, Inc.
Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality
- Trial name
- COMMENCE-P (NCT02656290)
- Testing
- Edwards Pericardial Aortic Bioprosthesis Model 11000A
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Replacement, Antithrombotic Therapy
Apixaban for the Prevention of Latent Biological Valve Thrombosis
Background: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence.
- Conditions
- Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis, Rapid Deployment Valves
- Trial name
- NCT06184113
- Testing
- Aortic valve replacement surgery, Computed tomography, Echocardiography
- Where
- Croatia
- Volunteers
- 166 people
- Sponsor
- Clinical Hospital Centre Zagreb
Cardiac Surgery-CABG, Cardiac Valve Replacement
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
- Trial name
- EPORT (NCT02802592)
- Testing
- Epogen, Normal Saline
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Johns Hopkins University
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
Anesthesia, General
Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR
The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT05035069
- Testing
- Ciprofol, Propofol
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Transcatheter Aortic Valve Replacement, Coronary Artery Disease
Coronary Artery Disease Assessment Strategies in TAVI Patients
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.
- Conditions
- Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors
- Trial name
- CAT (NCT06559332)
- Testing
- Risk-based CAD management, Invasive coronary angiography
- Where
- Switzerland
- Volunteers
- 546 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis, Heart Valve Diseases
Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease
- Trial name
- QUALITY-AVR (NCT02726087)
- Testing
- ministernotomy, Full sternotomy
- Where
- Spain
- Volunteers
- 96 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Coronary Artery Disease, Mitral Valve Regurgitation
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure
- Trial name
- NCT00853632
- Testing
- CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
- Where
- 15 sites in United States, Austria and 2 more
- Volunteers
- 329 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic…
- Trial name
- TAVI (NCT06154642)
- Testing
- Determination of arterial compliance using blood pressure waveform analysis, Measurement of plasma Vascular Endothelium Growth Factor, Skin temperature gradient
- Where
- Switzerland
- Volunteers
- 21 people
- Sponsor
- University Hospital, Geneva
Mitral Insufficiency, Heart Valve Disease
Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)
The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered…
- Conditions
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease
- Trial name
- NCT02515539
- Testing
- CardiAQ TMVI System (Transapical & Transfemoral DS)
- Sponsor
- Edwards Lifesciences
Transcatheter Aortic Valve Replacement (TAVR)
EasyCrossTM Device-Self-centering Catheter
VIVHEART EasyCross™ is a self-centering device for inserting a guidewire through a heart valve. It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms…
- Trial name
- VIV-FIH (NCT06412354)
- Testing
- EasyCross™ first-in human
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Vivheart s.r.l.
Aortic Stenosis
Reactive Oxygen Species Following Aortic Valve Replacement
Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for patients with severe symptomatic aortic stenosis (AS).
- Trial name
- ROS (NCT02841917)
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
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