Clinical trials: Aortic Valve
Aortic Stenosis
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe…
- Trial name
- NCT02903420
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 2 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Edwards Lifesciences
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
REST Study: Left Ventricular Regression European Study
The purpose of this study is to obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance…
- Trial name
- NCT00256165
- Testing
- Tissue valve
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
ACURATE TA™ Valve Implantation Registry: SAVI 2
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to…
- Trial name
- TA-SAVI2 (NCT02663375)
- Testing
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Where
- 27 sites in Austria, Germany and 2 more
- Volunteers
- 250 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis
Engager Direct Aortic Clinical Study
To confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
- Trial name
- NCT01789567
- Testing
- Engager™ aortic valve
- Where
- 6 sites in Czechia, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis
Vivio AS (Aortic Stenosis) Detection Study
Evaluate the sensitivity and specificity of the Vivio System when used as an aid in the identification of heart sounds associated with severe aortic stenosis.
- Trial name
- NCT04066634
- Testing
- Vivio System
- Where
- 3 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ventric Health, LLC
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
- Trial name
- MAPLE-HCM (NCT05767346)
- Testing
- Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg), Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
- Where
- 71 sites in United States, Brazil and 11 more
- Volunteers
- 175 people
- Sponsor
- Cytokinetics
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
Coronary Arterial Disease (CAD), Arterial Stiffness
SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment
This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and pulse wave characteristics and explore its potential in assessment of coronary artery disease, aortic stenosis and…
- Conditions
- Coronary Arterial Disease (CAD), Arterial Stiffness, Aortic Valve Disease, Heart Failure
- Trial name
- NCT07001007
- Testing
- Coronary Computer Tomography (CCTA), Laser Doppler Vibrometry and single-lead ECG, Echocardiography
- Where
- Sweden
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- HJN Sverige AB/Neko Health
Atrial Fibrillation, Coronary Artery Disease
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the…
- Trial name
- NCT00157807
- Testing
- bipolar radiofrequency ablation of persistent and permanent AF
- Where
- 5 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Medtronic Cardiac Surgery
Cardiomyopathy
Natural History Study in Pediatric Patients With MYBPC3 Mutation-associated Cardiomyopathy
The objective of this study is to collect information on patients with cardiomyopathy (CM) due to mutations in the MYBPC3 gene, to evaluate their disease course, burden of illness, risk factors for this disease, and the quality…
- Trial name
- MyCLIMB (NCT05112237)
- Where
- 29 sites in United States, Canada and 2 more
- Volunteers
- 200 people
- Sponsor
- Tenaya Therapeutics
Hypertrophic Cardiomyopathy (HCM), Cardiac Imaging
ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access
This study evaluates whether healthcare providers without specialized ultrasound training can use UltraSight's machine learning based Guidance Software to perform limited transthoracic echocardiography in patients with…
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Cardiac Imaging, Echocardiography, Mavacamten
- Trial name
- NCT07155434
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- UltraSight
TAVI(Transcatheter Aortic Valve Implantation)
ROTAO 1 - Feasibility and Safety of the TAVIPILOT Tele-operated Robot During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
The TAVIPILOT tele-operated robot by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR.
- Trial name
- NCT07152574
- Testing
- TAVR using a tele-operated Robot
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Hypertrophic Cardiomyopathy
Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM
This is a first-in-human, non-randomized, open-label study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic hypertrophic cardiomyopathy (HCM) caused by…
- Trial name
- MyPEAK-1 (NCT05836259)
- Testing
- TN-201
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tenaya Therapeutics
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Coronary Artery Disease
Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR
The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after…
- Trial name
- FORTUNA (NCT03665389)
- Testing
- iFR / FFR measurement
- Volunteers
- 25 people
- Sponsor
- Kobe University
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Perceval S Aortic Heart Valve Study- North America
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- NCT01810679
- Testing
- Perceval S Aortic Heart Valve
- Where
- 21 sites in United States
- Volunteers
- 355 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Heart Valve Diseases
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or…
- Trial name
- Enable (NCT01116024)
- Testing
- ATS 3f Enable Aortic Bioprosthesis Model 6000
- Where
- 10 sites in Austria, Germany and 3 more
- Volunteers
- 173 people
- Sponsor
- Medtronic Cardiovascular