Clinical trials: Stenoses, Aortic Valve
Aortic Valve Stenosis
Transfemoral Implant of Inovare® Transcatheter Valve
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
- Trial name
- NCT05531578
- Testing
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
- Where
- 4 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Aortic Stenosis, Coronary Artery Disease
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis.
- Conditions
- Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis
- Trial name
- COMPLETE TAVR (NCT04634240)
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- 72 sites in United States, Canada
- Volunteers
- 4,000 people
- Sponsor
- University of British Columbia
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Aortic Valve Stenosis
Sentinel Low Risk Registry
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
- Trial name
- NCT04131127
- Testing
- Sentinel Device
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- CVPath Institute Inc.
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Aortic Insufficiency, Aortic Stenosis
Automated Phonocardiography Analysis in Adults
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers…
- Conditions
- Aortic Insufficiency, Aortic Stenosis, Mitral Insufficiency, Mitral Insufficiency and Aortic Stenosis
- Trial name
- NCT03600051
- Testing
- Automated Heart Murmur Detection AI
- Where
- Austria
- Volunteers
- 90 people
- Sponsor
- CSD Labs GmbH
Aortic Valve Stenosis, Valve Heart Stenosis
Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)
Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy.
- Trial name
- E-AVR (NCT03143361)
- Testing
- Aortic valve replacement
- Where
- Italy
- Volunteers
- 8,000 people
- Sponsor
- University of Parma
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Platelet Adhesion in the Pathobiology of Aortic Stenosis
Aortic stenosis (AS) is a serious and common condition that affects 2-3% of the population >65 years of age in Western countries.
- Trial name
- NCT05550896
- Testing
- Echocardiogaphy
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Virginia
HCM - Hypertrophic Cardiomyopathy
Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR
his is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of Henagliflozin (an SGLT2 inhibitor) on myocardial fibrosis burden in patients with non-obstructive hypertrophic…
- Trial name
- NCT07294495
- Testing
- Henagliflozin (SGLT2 Inhibitor)
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai East Hospital
Aortic Valve Stenosis
VitaFlow LIBERTY Europe
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the…
- Trial name
- NCT06535659
- Testing
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Where
- 9 sites in Ireland, Italy and 3 more
- Volunteers
- 222 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Stenosis
Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis
To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis.
- Trial name
- NCT02010177
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Cardiac Amyloidosis, Amyloidosis in Transthyretin (TTR)
Prevalence of Transthyretin Amyloidosis in Hypertrophic Cardiomyopathy
Cardiac amyloidosis are related to the accumulation of fibrillar proteins in the extracellular leading to disruption of the cardiac tissue architecture.
- Conditions
- Cardiac Amyloidosis, Amyloidosis in Transthyretin (TTR), Hypertrophic Cardiomyopathy (HCM)
- Trial name
- Amylo (NCT01623245)
- Where
- France
- Volunteers
- 294 people
- Sponsor
- Thibaud Damy
Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects. 2.
- Trial name
- NCT04783766
- Testing
- CK-3773274
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals
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 Stenosis, Amyloid
Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement
Background (Context): Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart.
- Trial name
- AORTICMARKER (NCT07105501)
- Where
- Spain
- Volunteers
- 110 people
- Sponsor
- Germans Trias i Pujol Hospital
Aortic Stenosis, Severe
The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured…
- Trial name
- CardioFit (NCT06818110)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Coronary Artery Disease, Aortic Valve Stenosis
Functional Assessment in TAVI: FAITAVI
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated…
- Trial name
- FAITAVI (NCT03360591)
- Testing
- Physiologically-guided strategy
- Where
- Italy
- Volunteers
- 320 people
- Sponsor
- Universita di Verona
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