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

NCT02847546 | Completed

• 1 other identifier: BPV-14-004
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• 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)

Interventions

True™ Flow Valvuloplasty Perfusion Catheter DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Leipzig Heart Institute GmbH

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Axel Linke, Prof.Dr.med.

  Helios Health Institute GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 28, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

DE (1)