Clinical trials: Valve Disease, Aortic
Aortic Valve Stenosis
Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)
Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality.
- Trial name
- TAVIguide (NCT03196596)
- Testing
- Computer simulation
- Where
- 5 sites in Belgium, Denmark and 3 more
- Volunteers
- 80 people
- Sponsor
- Erasmus Medical Center
Aortic Stenosis
REPRISE Next Generation Delivery System
To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are…
- Trial name
- NGDS (NCT02329496)
- Testing
- Lotus Valve and LOTUS Edge Valve System
- Where
- 2 sites in Australia
- Volunteers
- 38 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD)
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating…
- Conditions
- Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD), Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- TAVR-CT (NCT07107568)
- Testing
- Standard Invasive Coronary Angiography, PCD-CT-Guided Diagnostic Strategy
- Where
- 2 sites in Austria
- Volunteers
- 700 people
- Sponsor
- Medical University Innsbruck
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
Aortic Valve Disease, Aortic Aneurysm
Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)
Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body…
- Trial name
- ARTIK (NCT06286358)
- Testing
- Kinocardiography
- Where
- Belgium
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Université Libre de Bruxelles
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
Cardiac Disease
Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)
The purpose of this study is to determine whether long-term treatment with a beta-blocker (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given to adult patients with bicuspid aortic valve…
- Trial name
- BAV (NCT01202721)
- Testing
- Atenolol, Telmisartan
- Where
- 13 sites in Canada
- Volunteers
- 85 people
- Sponsor
- Hamilton Health Sciences Corporation
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
Aortic Valve Disease
TAVR for Aortic Valve Disease
Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement…
- Trial name
- NCT05439863
- Testing
- transcatheter heart valve
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
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