Clinical trials: Stenoses, Aortic
Symptomatic Aortic Stenosis
Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access
The purpose of this clinical investigation is to evaluate the use of the Portico ALC Delivery System to place a transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or TAo.
- Trial name
- PorticoALTEU (NCT02088021)
- Testing
- Portico Transcatheter Aortic Valve
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.
- Trial name
- NCT01475799
- Testing
- Replacement of the Aortic Stenotic Valve
- Where
- 12 sites in France, Germany and 3 more
- Volunteers
- 112 people
- Sponsor
- Direct Flow Medical, Inc.
Obstructive Hypertrophic Cardiomyopathy
Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects
The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.
- Trial name
- NCT06354556
- Testing
- HRS-1893 tablet, Verapamil tablet
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
Stenosis, Regurgitation, Aortic
Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement
This study intends to reinforce the current clinical information regarding safety and efficacy of the Dokimos Plus aortic valve prosthesis in patients in whom an aortic valve replacement with a bioprosthesis has been indicated.
- Trial name
- NCT04370041
- Testing
- Dokimos Plus aortic valve
- Where
- 3 sites in Spain
- Volunteers
- 80 people
- Sponsor
- Swan Medical S. L.
Aortic Valve Stenosis
Valvosoft First-In-Man 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-man
- Trial name
- NCT03779620
- Testing
- Ultrasound treatment of Calcified aortic valve
- Where
- 2 sites in France, Netherlands
- Volunteers
- 30 people
- Sponsor
- Cardiawave SA
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
Aortic Valve Stenosis
The Leaflex™ Brazilian Standalone Study
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.
- Trial name
- NCT05052684
- Testing
- Leaflex™ Performer
- Where
- Brazil
- Volunteers
- 1 people
- Sponsor
- Pi-cardia
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT05902897
- Testing
- Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
- Where
- 3 sites in Brazil
- Volunteers
- 913 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Aortic Valve Stenosis
Hydra Registry - UK
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the…
- Trial name
- NCT06507579
- Testing
- Hydra transcatheter aortic valve (THV) series
- Where
- 4 sites in United Kingdom
- Volunteers
- 250 people
- Sponsor
- Sahajanand Medical Technologies Limited
Vascular Diseases
A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the…
- Trial name
- FLOWGRAFT (NCT05145517)
- Testing
- Open repair
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- JOTEC GmbH
Hypertrophic Cardiomyopathy
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects.
- Trial name
- NCT02329184
- Testing
- MYK-461
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- MyoKardia, Inc.
Symptomatic Severe Aortic Stenosis
Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study
Early System Experience with the Abbott Balloon-expandable TAVI System
- Trial name
- EASE (NCT07082426)
- Testing
- Balloon expandable TAVI
- Where
- 3 sites in Georgia, Uzbekistan
- Volunteers
- 8 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Aortic Stenosis
Sorin Universal REgistry on Aortic Valve Replacement
Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide.
- Trial name
- SURE-AVR (NCT02679404)
- Where
- 52 sites in United States, Australia and 15 more
- Volunteers
- 2,758 people
- Sponsor
- Corcym S.r.l
Aortic Valve Stenosis, Intracranial Embolism and Thrombosis
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI…
- Trial name
- NAUTILUS (NCT04704258)
- Testing
- TAVI (Transcatheter Aortic Valve Implant), FLOWer Embolic Protection System
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 100 people
- Sponsor
- AorticLab Srl
Aortic Stenosis
Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis
The purpose of this study is to evaluate the effectiveness of impedance cardiography (ICG), the HYPERGRAPH test, in detecting left ventricular decompensation in patients with aortic stenosis, compared to cardiac magnetic…
- Trial name
- NCT07230964
- Testing
- Impedance Cardiography Upright/Supine Test
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Dermed Diagnostics, Inc.
Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy
A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.
- Conditions
- Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy, Non-obstructive Hypertrophic Cardiomyopathy
- Trial name
- NCT03723655
- Testing
- mavacamten
- Where
- 68 sites in United States, Belgium and 11 more
- Volunteers
- 314 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis Symptomatic
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.
- Trial name
- 2011-03 (NCT03752996)
- Testing
- ACURATE TF™ Aortic Valve System
- Where
- 5 sites in Brazil, Germany
- Volunteers
- 140 people
- Sponsor
- Symetis SA
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.