Clinical trials: Stenosis Coronary
Right Ventricular Outflow Tract Stenosis
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.
- Trial name
- NCT02071654
- Testing
- Venus P-valve transcatheter implantation
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
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
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Aortic Stenosis
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
- Trial name
- SOURCE 3 (NCT02698956)
- Testing
- TAVI (Transcatheter Aortic Valve Implantation)
- Where
- 73 sites in Denmark, Finland and 8 more
- Volunteers
- 2,000 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Calcific, Aortic Valve Stenosis
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.
- Trial name
- PROGRESS (NCT04889872)
- Testing
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,250 people
- Sponsor
- Edwards Lifesciences
Coronary Stenosis, Coronary Artery Disease
3D-QFR in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.
Physiology-based decision-making about the need for revascularisation in patients with stable coronary heart disease has consistently proven better clinical outcomes than a merely anatomical approach.
- Trial name
- NCT05251012
- Volunteers
- 803 people
- Sponsor
- Pablo Manuel Fernandez Corredoira
Coronary Stenosis, Coronary Occlusion
IRIS- DESyne X2 in the IRIS-DES Registry
This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.
- Conditions
- Coronary Stenosis, Coronary Occlusion, Coronary Disease
- Trial name
- IRIS DESyne X2 (NCT03588481)
- Testing
- DESyne X2
- Where
- 6 sites in South Korea
- Volunteers
- 1,000 people
- Sponsor
- Seung-Jung Park
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Myocardial Ischemia
Assessment of Coronary Stenoses Using Coronary CT-angiography and Non-invasive Fractional Flow Reserve Measurement.
The purpose of this study is to determine whether a novel non-invasive method to estimate coronary blood flow (FFRct) is applicable to evaluate the functional significance of coronary stenoses in non-culprit vessels in a…
- Trial name
- NCT01739075
- Where
- Denmark
- Volunteers
- 64 people
- Sponsor
- University of Aarhus
Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves
PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device
This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs.
- Trial name
- PROTECT (NCT02895737)
- Testing
- TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra, TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems, TAVI: CoreValve® Evolut R™, CoreValve Medtronic
- Where
- Germany
- Volunteers
- 328 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475267
- Testing
- Trifecta aortic heart valve
- Where
- 5 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Cardiovascular Diseases
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic…
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Trial name
- NOTION-4 (NCT06449469)
- Testing
- Rivaroxaban, Acetylsalicylic acid, Clopidogrel
- Where
- 2 sites in Denmark
- Volunteers
- 352 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Healthy Adults (Full Study and Extension Phase), Hypertrophic Cardiomyopathy or Dilated Cardiomyopathy
A Pilot Project Exploring the Impact of Whole Genome Sequencing in Healthcare
The MedSeq™ Project seeks to explore the impact of incorporating information from a patient's whole genome sequence into the practice of clinical medicine.
- Trial name
- NCT01736566
- Testing
- Family History + Whole Genome Sequencing, Family History Only
- Where
- United States
- Volunteers
- 213 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Obstructive Hypertrophic Cardiomyopathy
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.
- Trial name
- COMPASS-HCM (NCT06551129)
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Bristol-Myers Squibb
Hypertrophic Cardiomyopathy (HCM), Cardiomyopathy
Large Language Models To Improve the Quality of Care of Cardiology Patients
This study evaluates the impact of large language models (LLMs) versus traditional decision support tools on clinical decision-making in cardiology.
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Cardiomyopathy, Genetic Disease, Cardiology
- Trial name
- NCT06935253
- Testing
- Large Language Model
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Aortic Valve Stenosis
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
- Trial name
- NCT04665596
- Testing
- Ultrasound treatment
- Where
- Serbia
- Volunteers
- 10 people
- Sponsor
- Cardiawave SA
Cardiomyopathy
Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients
Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide. Tow echo examination, few hours apart, that includes strain rate will be done to each patient.
- Trial name
- NCT02917395
- Testing
- echocardiography
- Volunteers
- 50 people
- Sponsor
- Rabin Medical Center
Transcatheter Aortic Valve Implantation (TAVI)
Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe
Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI).
- Trial name
- BENCHMARK (NCT04579445)
- Testing
- Education on tailored Quality Improvement measures
- Where
- 28 sites in Austria, Czechia and 5 more
- Volunteers
- 2,408 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Coronary Disease, Coronary Artery Disease
XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study
XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- XIENCE V India (NCT00631228)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent
- Where
- 18 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
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