Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation

NCT ID: NCT02847546

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-10-31

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)).

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

True™ Flow Valvuloplasty Perfusion Catheter

Balloon Aortic Valvuloplasty as preparation step in implantation of a Tanscatheter Aortic Valve Implantation (TAVI).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Linke, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Helios Health Institute GmbH

Locations

Leipzig Heart Institute GmbH

Leipzig, , Germany

Countries

Germany

Other Identifiers

BPV-14-004

Identifier Type: -

Identifier Source: org_study_id