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

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).

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: True™ Flow Valvuloplasty Perfusion Catheter

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
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Leipzig Heart Institute GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be males or non-pregnant females, at least 18 years of age.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful dilatation of the aortic valve using the True™ Flow Valvuloplasty Perfusion Catheter.	Defined as complete opening of the True™ Flow Valvuloplasty Perfusion Catheter by visual estimate and the ability of the inflated True™ Flow Valvuloplasty Perfusion balloon to stay stationary with clinically acceptable intraventricular pressure under rapid pacing, reduced pacing, or without pacing.	Duration of Dilatation of Balloon during Procedure (<120 minutes)
Freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure.	Defined as the time the study device catheter is introduced until the time TAVI device system is introduced.	Duration of Dilatation of Balloon during Procedure (<120 minutes)

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Axel Linke, Prof.Dr.med., Leipzig Heart Institute GmbH

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: BPV-14-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided