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Freedom SOLO Stentless Heart Valve Study (SOLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01115907
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
Sorin Group USA, Inc.

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

Condition or disease Intervention/treatment Phase
Aortic Stenosis Aortic Insufficiency Device: Freedom SOLO Stentless Heart Valve Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America
Study Start Date : December 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam

Arm Intervention/treatment
Experimental: 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.
Device: Freedom SOLO Stentless Heart Valve
Freedom SOLO Stentless Heart Valve

Primary Outcome Measures :
  1. Safety will be determined by incidence rate of adverse events [ Time Frame: 1 year ]
    The complication and survival rates for the SOLO valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported in the literature for other stentless bioprostheses and stented pericardial valves.

Secondary Outcome Measures :
  1. Efficacy will be determined by hemodynamics [ Time Frame: 1 year ]
    The hemodynamic performance of the SOLO valve will be compared to that reported in the literature for other stentless bioprostheses and stented pericardial valves.

  2. Effectiveness will be determined by NYHA Classification comparisons [ Time Frame: 1 year ]
    Clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01115907

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Indiana
St. Vincent Heart Center
Indianapolis, Indiana, United States, 46240
United States, Michigan
Oakwood Hospital
Dearborn, Michigan, United States, 48124
United States, New Jersey
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
University of Bristish Columbia St. Paul Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Sorin Group USA, Inc.
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Principal Investigator: Eric Roselli, M.D. The Cleveland Clinic
Principal Investigator: David Heimansohn, MD St. Vincent Heart Center
Principal Investigator: Alex Zapolanski, MD The Valley Hospital
Principal Investigator: Vinod Thourani, MD Emory University
Principal Investigator: Reza Dabir, MD Oakwood Hospital
Principal Investigator: Ali Khoynezhad, MD Cedars-Sinai Medical Center
Principal Investigator: Pranshanth Vallabhajosyula, MD University of Pennsylvania
Principal Investigator: Michael Moront, MD The Toledo Hospital
Principal Investigator: Scott Goldman, MD Main Line Health
Principal Investigator: Shaohua Wang, MD University of Alberta
Principal Investigator: L. Ray Guo, MD London Health Science Centre
Principal Investigator: Andrew Maitland, MD Foothills Medical Center
Principal Investigator: Michael Moon, MD St. Boniface Hospital
Principal Investigator: Pierre Voisine, MD Institut Universitaire de Cardiologie et de Pneumologie de Québec
Principal Investigator: Jian Ye, MD St. Paul's Hospital
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Responsible Party: Sorin Group USA, Inc. Identifier: NCT01115907    
Other Study ID Numbers: G100014
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by Sorin Group USA, Inc.:
Valve replacement
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction