Clinical trials: Aortic Valve Stenosis
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
Aortic Valve Stenosis, Aortic Valve Failure
Portico and Navitor India Clinical Trial
The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05171712
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 6 sites in India
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in…
- Trial name
- REPRISE EDGE (NCT02854319)
- Testing
- LOTUS Edge Valve System
- Where
- 3 sites in Denmark, France and 1 more
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
- Trial name
- COMPARE-TAVI (NCT06470022)
- Testing
- Medtronic Evolut FX, Edwards Sapien 3 Ultra Resilia
- Where
- Denmark
- Volunteers
- 1,370 people, healthy volunteers welcome
- Sponsor
- Christian Juhl Terkelsen
Aortic Stenosis
ACURATE Prime XL Human Feasibility Study
To evaluate feasibility and safety of the ACURATE Prime™ XL Transfemoral Aortic Valve System for transcatheter aortic valve implantation (TAVI) in subjects with severe native aortic stenosis who are indicated for TAVI.
- Trial name
- NCT05224245
- Testing
- ACURATE Prime XL Transfemoral Aortic Valve System
- Where
- 3 sites in Australia
- Volunteers
- 13 people
- Sponsor
- Boston Scientific Corporation
Symptomatic Aortic Stenosis
ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.
- Trial name
- NCT03143686
- Testing
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Where
- 17 sites in Argentina, Germany and 2 more
- Volunteers
- 250 people
- Sponsor
- Symetis SA
Intellectual Disability, Neurodevelopmental Disorders
Physical Activity and Community EmPOWERment Project
Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease…
- Conditions
- Intellectual Disability, Neurodevelopmental Disorders, Autism Spectrum Disorder, Down Syndrome
- Trial name
- PACE (NCT06740162)
- Testing
- PACE Program
- Where
- 2 sites in United States
- Volunteers
- 376 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Aortic Valve Disease
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
- Trial name
- ASCEND (NCT05082454)
- Testing
- Open repair
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 108 people
- Sponsor
- JOTEC GmbH
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Severe Aortic Valve Stenosis, Valvular Heart Disease
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis.
- Conditions
- Severe Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve Stenosis
- Trial name
- HYSPANIA (NCT07566624)
- Testing
- Hydra THV
- Where
- 7 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Fundación EPIC
Coronary Disease, Aortic Valve Stenosis
Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients
It is a common understanding that patients with coronary heart disease are suffering, among others, from reduced myocardial perfusion.
- Trial name
- CCT/MPERF (NCT02361996)
- Where
- 3 sites in Austria, Russia and 1 more
- Volunteers
- 690 people
- Sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
Hypertrophic Cardiomyopathy
Viz HCM (ECG Assist) Utilization Workflow Pilot
This is a prospective, open-label, multi-center workflow pilot. Viz HCM will be implemented at each participating site and all conforming incoming ECG recordings within a 6-month enrollment period will be analyzed using Viz HCM.
- Trial name
- NCT06600256
- Testing
- Viz HCM ECG Review, Baseline Effectiveness Cohort
- Where
- 5 sites in United States
- Volunteers
- 217 people
- Sponsor
- Viz.ai, Inc.
Bleeding, Von Willebrand Disease
Acquired Von Willebrand Syndrome in Severe Aortic Stenosis
Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences.
- Conditions
- Bleeding, Von Willebrand Disease, Aortic Stenosis
- Trial name
- NCT00805051
- Where
- Switzerland
- Volunteers
- 60 people
- Sponsor
- University Hospital, Basel, Switzerland
Cardiomyopathy, Hypertrophic
Study of Exercise Training in Hypertrophic Cardiomyopathy
The investigators propose a pilot randomized controlled trial to determine the safety and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy.
- Trial name
- RESET-HCM (NCT01127061)
- Testing
- Exercise training
- Where
- 2 sites in United States
- Volunteers
- 136 people
- Sponsor
- University of Michigan
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Neuropsychological and Neuroimaging Evaluation of the Cognitive Impairment in Aortic Valve Replacement (ARTiCO)
OBJECTIVE: To evaluate changes in cognitive performance in the early postoperative (1 month) and late (1 year) postoperative period in patients undergoing aortic valve replacement (SVAo) with surgery (SVA_Q) or transcatheter…
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Surgical Treatment, Cognitive Impairment
- Trial name
- ARTiCO (NCT05235529)
- Testing
- Aortic valve replacement, TAVI
- Where
- Spain
- Volunteers
- 72 people
- Sponsor
- Germans Trias i Pujol Hospital
Aortic Valve Stenosis
Post-Dilatation in Balloon-Expandable TAVI Prostheses
Asymmetrical and inadequate expansion of transcatheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bioprosthetic valve dysfunction (BVD) and…
- Trial name
- DUOTAP (NCT07477002)
- Testing
- Post-dilatation
- Where
- Austria
- Volunteers
- 146 people
- Sponsor
- Medical University of Vienna
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) versus placebo in adults with symptomatic hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction.
- Trial name
- SEQUOIA-HCM (NCT05186818)
- Testing
- Aficamten (5 mg, 10 mg, 15 mg, and 20 mg)
- Where
- 114 sites in United States, China and 12 more
- Volunteers
- 282 people
- Sponsor
- Cytokinetics
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Stenosis, Aortic Stenosis With Bicuspid Valve
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic…
- Trial name
- NCT04722796
- Testing
- TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution), TAVR with Venus A plus using annular sizing and THV implantation technique
- Where
- 18 sites in China
- Volunteers
- 508 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Valve Stenosis
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic…
- Trial name
- TAVI (NCT06154642)
- Testing
- Determination of arterial compliance using blood pressure waveform analysis, Measurement of plasma Vascular Endothelium Growth Factor, Skin temperature gradient
- Where
- Switzerland
- Volunteers
- 21 people
- Sponsor
- University Hospital, Geneva
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