Clinical trial NCT01156272: Post Market ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm
Official title: 3f 19mm IDE Study Rev D
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Valve Diseases
Keywords: Isolated aortic valve replacement
heart valve
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were previously implanted with the ATS 3f Aortic Bioprosthesis Model 1000 (size 19mm) between the dates 1-Jan-2009 and 31-Dec-2009 and who meet the eligibility criteria.

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

Detailed description: A multi-center, post market, non-randomized trial, designed to obtain safety and efficacy data from patients implanted with the size 19mm Model 1000 heart valve. Each enrolled patient will be followed until one year post-implantation. Data will be collected both retrospectively and prospectively, on patients who were implanted from 1-Jan-2009 to 31-Dec-2009 with the 19mm Model 1000. The data collected will be pooled with the data currently collected, under the U.S. Food and Drug Administration (FDA) IDE Number G01284 for submission to the U.S. FDA.

Eligibility criteria: Inclusion Criteria:

* The patient required isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction with an ATS 3f® Aortic Bioprosthesis Model 1000 (size 19mm) between the dates of 1-Jan-2009 and 31-Dec-2009. The three remaining heart valves must be of native tissue.
* The patient is geographically stable and willing to return to the implant center for any required follow-up visits.
* The patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.

Exclusion Criteria:

* The patient is twenty (20) or less than twenty years of age.
* The patient is an intravenous drug and/or alcohol abuser.
* The patient presented for implant with active endocarditis.
* The patient presented for implant with congenital bicuspid aortic anatomy.
* The patient had a previously implanted prosthetic valve that was not replaced by the study valve.
* The patient required mitral, tricuspid or pulmonic valve replacement.

Primary outcomes:
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
measure: Blood Data
timeFrame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
measure: Adverse/complication rates
timeFrame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre, Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: Medtronic
name: Mike Boulware, PhD
role: STUDY_DIRECTOR
References: