Clinical trials: Stenoses, Aortic
Aortic Valve Stenosis, Aortic Stenosis
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Aortic Valve Disease
- Trial name
- NCT07276711
- Testing
- EmStop Embolic Protection System, Boston Scientific Sentinel
- Where
- 7 sites in United States
- Volunteers
- 663 people
- Sponsor
- EmStop Inc
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
Aortic Stenosis, Amyloid
Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement
Background (Context): Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart.
- Trial name
- AORTICMARKER (NCT07105501)
- Where
- Spain
- Volunteers
- 110 people
- Sponsor
- Germans Trias i Pujol Hospital
Aortic Valve Stenosis
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
- Trial name
- REBOOT-PARADOX (NCT03863132)
- Testing
- TAVR
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Cardiovascular Diseases, Hypertrophic Cardiomyopathy (HCM)
AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA
The goal of this observational and diagnostic study is to develop and validate an artificial intelligence assisted approach for coronary computer tomography angiography-(CCTA)-based screening and diagnosis of cardiomyopathies in…
- Conditions
- Cardiovascular Diseases, Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Restrictive Cardiomyopathy
- Trial name
- Atlantis (NCT06748261)
- Testing
- CCTAI model
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Valve Stenosis
Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis
This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis.
- Trial name
- NCT02049203
- Testing
- Ataciguat
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Jordan D. Miller, Ph.D.
Aortic Valve Stenosis, Aortic Valve Disease
Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the 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 Stenosis, Aortic Valve Disease, Aortic Valve Regurgitation
- Trial name
- NCT06737757
- Testing
- Artificial polymer heart valves, Bovine pericardial aortic valve
- Volunteers
- 198 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Atrial Fibrillation, Stroke
Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation
The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement.
- Conditions
- Atrial Fibrillation, Stroke, Transient Ischemic Attack, Bleeding
- Trial name
- CAREAVR (NCT02626871)
- Where
- Finland
- Volunteers
- 850 people
- Sponsor
- University of Turku
Aortic Valve Stenosis
Ascending Aortic Dilation in BiAV After TAVR
This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).
- Trial name
- NCT03051334
- Testing
- diagnosed as bicuspid aortic valve
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Seoul National University Hospital
Aortic Valve Stenosis
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the…
- Trial name
- POLESTAR (NCT03910751)
- Testing
- Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
- Where
- 15 sites in Belgium, Canada and 2 more
- Volunteers
- 252 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Disease
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic…
- Trial name
- SAPIEN3 (NCT01808287)
- Testing
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Where
- 17 sites in Canada, France and 3 more
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Heart Valve Diseases, Aortic Valve Disease
Rapid Non-invasive Detection of Aortic Stenosis
Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from…
- Conditions
- Heart Valve Diseases, Aortic Valve Disease, Heart Murmurs
- Trial name
- NCT04024566
- Testing
- Vivio System
- Where
- United States
- Sponsor
- Ventric Health, LLC
Hypertrophic Cardiomyopathy (HCM)
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.
- Trial name
- COLLIGO-HCM (NCT06372457)
- Testing
- Approved Hypertrophic Cardiomyopathy drug treatments, Mavacamten
- Where
- United States
- Volunteers
- 331 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis
Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis
One hundred patients with moderate to severe asymptomatic aortic stenosis (AS) will be asked to exercise on a treadmill. NT-pro-BNP levels will be drawn before and after exercise.
- Trial name
- AS-BNP (NCT00567437)
- Testing
- NT-pro-BNP levels
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Duke University
Aortic Valve Stenosis
SAPIEN 3 Ultra System PMCF
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
- Trial name
- NCT04555967
- Testing
- SAPIEN 3 Ultra System
- Where
- 11 sites in Austria, Canada and 6 more
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Cardiac Valve Disease, Aortic Valve Stenosis
Remote ECG Monitoring of TAVI Patients
After surgery, patients who undergo transcatheter aortic valve implantation (TAVI) are at risk of developing cardiac arrhythmias such as heart blocks and atrial fibrillation.
- Trial name
- NCT03810820
- Testing
- mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
- Where
- Canada
- Volunteers
- 240 people
- Sponsor
- Population Health Research Institute
Obstructive Hypertrophic Cardiomyopathy
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac…
- Trial name
- NCT06116968
- Testing
- Aficamten
- Where
- 12 sites in China
- Volunteers
- 40 people
- Sponsor
- Corxel Pharmaceuticals
Aortic Valve Stenosis
Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation
The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach…
- Trial name
- TAVIXS (NCT05672823)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 8 sites in Netherlands
- Volunteers
- 238 people
- Sponsor
- Radboud University Medical Center
Symptomatic Severe Aortic Stenosis
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Trial name
- NCT07116551
- Testing
- Abbott BE TAVI System
- Where
- 5 sites in United States, France
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
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