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

Aortic Valve Stenosis Clinical Trial

— True™Flow  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847546
• Other study ID #: BPV-14-004
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: January 9, 2017
• Start date: September 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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).

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• True™ Flow Valvuloplasty Perfusion Catheter
Balloon Aortic Valvuloplasty as preparation step in implantation of a Tanscatheter Aortic Valve Implantation (TAVI).

Locations

Country	Name	City	State
Germany	Leipzig Heart Institute GmbH	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	Yes