Brief Title
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
Official Title
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
Brief Summary
The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic Valve Implantation (TAVI).
Detailed Description
The BARD® True™ Flow Valvuloplasty Perfusion Catheter Study is a prospective, single-center, non-randomized, single-arm observational study intended to collect data to confirm the performance and safety of the BARD® True™ Flow Valvuloplasty Perfusion Catheter (True™ Flow catheter) when used for dilatation of the aortic valve in preparation for Transcatheter Aortic Valve Implantation (TAVI). This study will be conducted in conformance with the Declaration of Helsinki, applicable national privacy laws, and European, national regulations and International Organization for Standardization (ISO) requirements (ISO 14155:2011 (E)).
Study Type
Observational
Primary Outcome
Successful dilatation of the aortic valve using the True™ Flow Valvuloplasty Perfusion Catheter.
Condition
Aortic Valve Stenosis
Intervention
True™ Flow Valvuloplasty Perfusion Catheter
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
25
Start Date
September 2016
Completion Date
October 2016
Primary Completion Date
October 2016
Eligibility Criteria
Inclusion Criteria: - The subject voluntarily provides written informed consent prior to the collection of study-specific data or performance of study-specific procedures using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) for the site. - The subject is a male or non-pregnant female ≥ 18 years old. - The subject is undergoing TAVI for treatment of aortic stenosis. - The subject has an annulus diameter that can be treated with the available size device, in accordance with the Instructions For Use (IFU). Exclusion Criteria: - The patient is unable or unwilling to provide written informed consent. - The patient has a known allergy or sensitivity to contrast media that cannot be adequately pre-medicated. - The patient has had previous aortic valve replacement. - The patient has a known congenital aortic valve abnormality (e.g., bicuspid aortic valve). - The patient has echocardiographic evidence of intracardiac mass, or thrombus. - The patient has vascular conditions that make insertion and endovascular access to the aortic valve impossible. - The patient has another medical condition, which, in the opinion of the Investigator, may cause him/her to confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures. - The subject is currently participating in an investigational drug, biologic, or another device study that has not completed the study treatment or that clinically interferes with the objectives of the study.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Axel Linke, Prof.Dr.med., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02847546
Organization ID
BPV-14-004
Responsible Party
Sponsor
Study Sponsor
C. R. Bard
Study Sponsor
Axel Linke, Prof.Dr.med., Principal Investigator, Leipzig Heart Institute GmbH
Verification Date
January 2017