Clinical trials: Aortic Valve Disease
Cognitive Impairment
Impact of TAVI on Cognition, Mood and Health-related Quality of Life
In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a…
- Trial name
- NCT04371172
- Testing
- cognitive research battery, MRI, laboratory values
- Where
- Austria
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Aortic Valve Stenosis
Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
To observe the clinical outcomes of the different valve sizing strategies treating type-0 Bicuspid Aortic Stenosis (BAS) with self-expandable transcatheter aortic valve implantation (TAVI) valve, compared with those of a standard…
- Trial name
- START (NCT02541877)
- Testing
- Down sizing valve in type-0 BAS, Standard sizing valve in type-0 BAS, Standard sizing valve in TAS
- Where
- China
- Volunteers
- 159 people
- Sponsor
- Jian'an Wang,MD,PhD
Aortic Valve Stenosis, Aortic Valve Replacement
Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance
- Trial name
- FIBROTIC (NCT05404100)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 86 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Hypertrophic Cardiomyopathy, Obstructive
Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children
The primary purpose of this study was to demonstrate the safety and efficacy of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) in children and assessed its performance and functional outcomes in the…
- Trial name
- NCT06540183
- Testing
- Percutaneous intramyocardial septal radiofrequency ablation
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Xijing Hospital
Aortic Valve Disease
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.
- Trial name
- NCT00619151
- Testing
- Top Hat, Regent
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Sorin Group USA, 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
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
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
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
Calcific Aortic Valve Disease
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)
This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 2 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with…
- Trial name
- NCT05143177
- Testing
- Evogliptin
- Where
- 25 sites in United States, Canada
- Volunteers
- 486 people
- Sponsor
- REDNVIA Co., Ltd.
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
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