ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post Market ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm

NCT01156272

Heart Valve Diseases

WITHDRAWN

ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

NCT01116037

Heart Valve Diseases

TERMINATED NA

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)

NCT01757665

Aortic Stenosis Mitral Stenosis Aortic Valve Insufficiency +2 more

ACTIVE_NOT_RECRUITING NA

Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease

NCT00677638

Aortic Valve Disease

UNKNOWN NA

Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

NCT01051518

Aortic Valve Stenosis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ATS 3f Enable Aortic Bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. For these patients, there are a number of widely accepted prosthetic heart valves in use.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Valve Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3f Enable Aortic Bioprosthesis Model 6000

Single arm study

Group Type EXPERIMENTAL

ATS 3f Enable Aortic Bioprosthesis Model 6000

Intervention Type DEVICE

Replacement Aortic Heart Valve

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ATS 3f Enable Aortic Bioprosthesis Model 6000

Replacement Aortic Heart Valve

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue).
* The patient is geographically stable and willing to return to the implant site for follow-up visits.
* The patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study.
* If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure.

Exclusion Criteria

* The patient requires replacement of two or more valves.
* The patient is \< 20 years of age.
* The patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 24 months.
* The patient is an intravenous drug and/or alcohol abuser.
* The patient presents with active endocarditis or other systemic infection.
* The patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable Aortic Bioprosthesis (Model 6000) or placement of a rigid annuloplasty ring in the mitral position.
* The patient is participating in concomitant research studies of investigational products.
* The patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
* The patient has chronic renal failure.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No