Clinical trials: Aortic Stenosis
Hypertrophic Cardiomyopathy (HCM), Left Ventricular Hypertrophy
AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy
By harnessing artificial intelligence to decode the 12-lead electrocardiogram, the project will enable precise ECG-based phenotyping of hypertrophic cardiomyopathy-accurately classifying septal, apical, and other morphologic…
- Trial name
- NCT07263204
- Where
- China
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Severe Aortic Stenosis, Transcatheter Aortic Valve Implantation
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI
This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy…
- Trial name
- CT-CA (NCT03291925)
- Testing
- Selective invasive angiography based on CT/CCTA imaging., Procedure/Surgery: Invasive angiography
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Aortic Valve Stenosis
Comparison Between Manta and Prostar Closure Devices
Use of the closure device in patient with percutaneous transfemoral aortic valve replacement
- Trial name
- NCT05662748
- Testing
- Transfemoral aortic valve replacement
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- RWTH Aachen University
Aortic Stenosis
Conscious Sedation vs General Anesthesia in TAVR Patients
This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
- Trial name
- NCT03084978
- Testing
- General Anesthesia, Conscious Sedation
- Sponsor
- Montefiore Medical Center
Aortic Stenosis, Cardiac Valve Replacement Complication
Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to…
- Conditions
- Aortic Stenosis, Cardiac Valve Replacement Complication, Fragility
- Trial name
- NCT01845207
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 800 people
- Sponsor
- Jewish General Hospital
Hypertrophic Cardiomyopathy
Biventricular Pacing in Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced ability to exercise because of breatlessness, which can in…
- Trial name
- NCT00504647
- Testing
- Biventricular Pacemaker
- Where
- 3 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- University Hospital Birmingham
Aortic Valve Stenosis
The Leaflex™ Standalone Study Protocol
A prospective, multicenter, single-arm study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
- Trial name
- NCT04649099
- Testing
- Leaflex™ Performer
- Where
- Hungary
- Volunteers
- 33 people
- Sponsor
- Pi-cardia
Valvular Heart Disease
Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE
The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the…
- Trial name
- PREVUE-VALVE (NCT05357404)
- Where
- United States
- Volunteers
- 2,870 people, healthy volunteers welcome
- Sponsor
- Cardiovascular Research Foundation, New York
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic…
- Trial name
- PII S3i (NCT03222128)
- Testing
- TAVR
- Where
- 51 sites in United States
- Volunteers
- 1,074 people
- Sponsor
- Edwards Lifesciences
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
Non-ischemic Cardiomyopathy, Cardiomyopathies
Cardiovascular Multimodality Imaging Study
Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis.
- Conditions
- Non-ischemic Cardiomyopathy, Cardiomyopathies, Hypertrophic Cardiomyopathy, Right Ventricular Arrhythmogenic Cardiomyopathy
- Trial name
- NCT06610019
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Montefiore Medical Center
Bradycardia
Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement
Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation.
- Trial name
- NCT03180073
- Testing
- Ziopatch Pre discharge, Ziopatch at Discharge, Ziopatch at 2 months
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Severe Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Platelet Reactivity After TAVI: A Multicenter Pilot Study
A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use of double antiaggregation…
- Conditions
- Severe Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
- Trial name
- REAC-TAVI (NCT02224066)
- Testing
- Ticagrelor 90 mg twice per day during three months following TAVI, Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI
- Where
- 7 sites in Spain
- Volunteers
- 65 people
- Sponsor
- Hospital de Meixoeiro
Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency
Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery
The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnia and keeps sweep gas flow of the oxygenator constant during open heart surgery.
- Trial name
- NCT04202575
- Testing
- Tube clamping
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Karolinska University Hospital
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
A virtual, self-directed, and tailored early mobilization program called JUMPSTART, that aims to bridge cardiac rehabilitation intake for post-TAVR patients has been developed at the Hamilton General Hospital.
- Trial name
- NCT06040398
- Testing
- JUMPSTART exercise program
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Hamilton Health Sciences Corporation
Non-obstructive Hypertrophic Cardiomyopathy
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with…
- Trial name
- FORTITUDE-HCM (NCT07023614)
- Testing
- Ninerafaxstat 200mg MR
- Where
- 76 sites in United States, Austria and 9 more
- Volunteers
- 165 people
- Sponsor
- Imbria Pharmaceuticals, Inc.
Aortic Coarctation, Cardiomyopathy
Radiation-Free Heart Catheterization Using MRI
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation.
- Conditions
- Aortic Coarctation, Cardiomyopathy, Atrial Septal Defect, Aortic Stenosis
- Trial name
- NCT02739087
- Testing
- MRI guided cardiac catheterization, Magnetic resonance imaging
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Joshua Kanter
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
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
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