Freedom SOLO Stentless Heart Valve Study

Summary

The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.

Conditions

• Aortic Stenosis
• Aortic Insufficiency

Interventions

DEVICE

Freedom SOLO Stentless Heart Valve

Freedom SOLO Stentless Heart Valve

Sponsors & Collaborators

• Sorin Group USA, Inc.

  lead INDUSTRY

Principal Investigators

• Eric Roselli, M.D. · The Cleveland Clinic

• David Heimansohn, MD · St. Vincent Heart Center

• Alex Zapolanski, MD · The Valley Hospital

• Vinod Thourani, MD · Emory University

• Reza Dabir, MD · Oakwood Hospital

• Ali Khoynezhad, MD · Cedars-Sinai Medical Center

• Pranshanth Vallabhajosyula, MD · University of Pennsylvania

• Michael Moront, MD · The Toledo Hospital

• Scott Goldman, MD · Main Line Health

• Shaohua Wang, MD · University of Alberta

• L. Ray Guo, MD · London Health Science Centre

• Andrew Maitland, MD · Foothills Medical Center

• Michael Moon, MD · St. Boniface Hospital

• Pierre Voisine, MD · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

• Jian Ye, MD · St. Paul's Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• United States
• Canada

Study Locations