Clinical trials: Valve
Severe Aortic Valve Disease
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve
Objectives: This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.
- Trial name
- NCT04696926
- Testing
- Edwards Intuity TM Valve implantation
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Aortic Stenosis, Coronary Artery Disease
COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.
Although concomitant coronary artery disease (CAD) is frequent in patients with severe aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging.
- Trial name
- COMIC-AS (NCT04420325)
- Where
- 3 sites in Belgium
- Volunteers
- 116 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Aortic Regurgitation
Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR.
- Trial name
- NCT00624884
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Florence Nightingale Hospital, Istanbul
Atrial Flutter
Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.
- Trial name
- NCT00113178
- Testing
- Catheter-based cardiac cryoablation
- Volunteers
- 160 people
- Sponsor
- Boston Scientific Corporation
Hypertrophic Cardiomyopathy
Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis
Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure.
- Trial name
- NCT06381778
- Where
- Taiwan
- Volunteers
- 2,600 people
- Sponsor
- Far Eastern Memorial Hospital
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid…
- Conditions
- Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD)
- Trial name
- TRIUMPH (NCT07687485)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System
- Where
- 2 sites in United States
- Volunteers
- 700 people
- Sponsor
- Laplace Interventional, Inc
Aortic Stenosis
Biological Factors Associated With Subclinical Valvular Thrombosis
A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI).
- Trial name
- START (NCT03847948)
- Testing
- CT SCAN
- Where
- 2 sites in Spain
- Volunteers
- 166 people
- Sponsor
- Hospital San Carlos, Madrid
Cardiac Amyloidosis, Aortic Stenosis
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Aortic stenosis (AS) is the most common valvular heart disease. Once symptomatic with severe AS, outcome is poor unless the valve is replaced surgically or via transcatheter aortic valve replacement (TAVR).
- Trial name
- ATTRact-AS (NCT03029026)
- Testing
- Baseline assessment, Transthoracic echocardiography, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid scintigraphy
- Where
- 2 sites in United Kingdom
- Volunteers
- 581 people
- Sponsor
- Queen Mary University of London
Atrial Functional Mitral Regurgitation
Effects of VALsartan On atRIAl Mitral Regurgitation (VALORIA) - Pilot
The goal of this clinical trial is to learn whether valsartan can slow the progression of atrial functional mitral regurgitation (AFMR) in adults with preserved left ventricular ejection fraction.
- Trial name
- VALORIA-Pilot (NCT07539298)
- Testing
- Valsartan
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Jonathan Beaudoin
Aortic Valve Stenosis, Heart Valve Diseases
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)
Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female…
- Trial name
- RHEIA (NCT04160130)
- Testing
- Transcatheter aortic valve replacement
- Where
- 48 sites in Austria, Belgium and 10 more
- Volunteers
- 432 people
- Sponsor
- Optimapharm
Shock, Septic, Hyperlactatemia
Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery
The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system.
- Conditions
- Shock, Septic, Hyperlactatemia, Oliguria, Aortic Aneurysm, Abdominal
- Trial name
- RELASTANCE (NCT04388267)
- Testing
- Fluid challenge
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Central Hospital, Nancy, France
Cardiac Surgical Procedures, Coronary Artery Disease
Clinical Outcomes in Patients Treated With SternaLock Blu
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation.
- Conditions
- Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases
- Trial name
- SECURE (NCT03709693)
- Testing
- SternaLock Blu
- Where
- 4 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement
Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- Trial name
- NCT07691307
- Testing
- TruGamma System, Optimal medical therapy (OMT)
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Trulive Medical Co., Ltd
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Postoperative Delirium
Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation
Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications.
- Trial name
- NCT02585128
- Testing
- Delirium assessment, MMSE (Mini Mental State Examination), Barthel index
- Where
- Switzerland
- Volunteers
- 201 people
- Sponsor
- Cardiocentro Ticino
Hypertension, Aortic Stenosis, Calcific
Pressure Assessment to Improve Outcomes After TAVR: a Registry
At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures.
- Conditions
- Hypertension, Aortic Stenosis, Calcific, Quality of Life, Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT03923530
- Testing
- Eplerenone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- North Florida Foundation for Research and Education
Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy Symptom Release by BX1514M
Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is observed within the left ventricle which is…
- Trial name
- Light-CARMIDO (NCT02590809)
- Testing
- Treatment BX1514M, Walk distance test, Exercise echocardiography
- Where
- France
- Volunteers
- 38 people
- Sponsor
- University Hospital, Bordeaux
Mitral Valve Insufficiency
MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States
The objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Trial name
- MAVERIC US (NCT03311295)
- Testing
- ARTO System
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Mvrx, Inc.
Emphysema
Functional Lung Imaging in Patients With Respiratory Compromise Undergoing Endobronchial Valve Placement
Bronchoscopic lung volume reduction (BLVR) using endobronchial valves is effective in improving quality of life in patients suffering from emphysema.
- Trial name
- NCT05204875
- Testing
- X-ray Velocimetry
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Temple University
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