Freedom SOLO Stentless Heart Valve Study

NCT ID: NCT01115907

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-10-31

Brief Summary

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

Detailed Description

The SOLO clinical investigation is a prospective, non-randomized, multicenter trial of the SOLO Freedom heart valve implanted in patients requiring aortic valve replacement.

Conditions

Aortic Stenosis; Aortic Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Freedom SOLO stentless valve implant

Appropriate subjects will receive the Freedom SOLO stentless valve implant as a replacement for a diseased or damaged native or prosthetic aortic valve.

Group Type: EXPERIMENTAL

Freedom SOLO Stentless Heart Valve

Intervention Type: DEVICE

Freedom SOLO Stentless Heart Valve

Interventions

Freedom SOLO Stentless Heart Valve

Freedom SOLO Stentless Heart Valve

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The subject is male or female 18 years old or older.
• The subject or subject's legal representative is willing to sign the informed consent.
• The subject which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
• Any subject amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures.
• The subject is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
• Subject will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion Criteria

• The subject has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
• The subject requires a double or multiple valve replacement (a valve repair is not considered an exclusion criterion).
• The subject has a previously implanted SOLO valve, within the clinical study, that requires replacement.
• The subject has active endocarditis or myocarditis.
• The subject is or will be participating in a concomitant research study of an investigational product.
• The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
• The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject.
• The subject is pregnant, planning to become pregnant or lactating.
• The subject has a congenital bicuspid aortic valve.
• The subject is known to be noncompliant or is unlikely to complete the study.
• The subject is undergoing renal dialysis for chronic renal failure or has been diagnosed with hyperparathyroidism.
• The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
• The subject has extensive calcification of the aortic root where removal of the calcified tissue cannot be achieved.
• The subject has a significantly dilated aortic root that is not surgically corrected.
• The subject requires replacement of the aortic root / full root procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorin Group USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Roselli, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

David Heimansohn, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent Heart Center

Alex Zapolanski, MD

Role: PRINCIPAL_INVESTIGATOR

The Valley Hospital

Vinod Thourani, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Reza Dabir, MD

Role: PRINCIPAL_INVESTIGATOR

Oakwood Hospital

Ali Khoynezhad, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Pranshanth Vallabhajosyula, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Michael Moront, MD

Role: PRINCIPAL_INVESTIGATOR

The Toledo Hospital

Scott Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health

Shaohua Wang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

L. Ray Guo, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Science Centre

Andrew Maitland, MD

Role: PRINCIPAL_INVESTIGATOR

Foothills Medical Center

Michael Moon, MD

Role: PRINCIPAL_INVESTIGATOR

St. Boniface Hospital

Pierre Voisine, MD

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Jian Ye, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Emory University

Atlanta, Georgia, United States

St. Vincent Heart Center

Indianapolis, Indiana, United States

Oakwood Hospital

Dearborn, Michigan, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Toledo Hospital

Toledo, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

University of Bristish Columbia St. Paul Hospital

Vancouver, British Columbia, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

London Health Sciences Centre

London, Ontario, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Countries

United States; Canada

Other Identifiers

G100014

Identifier Type: -

Identifier Source: org_study_id