Freedom SOLO Stentless Heart Valve Study (SOLO)

Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America

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

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Aortic Insufficiency
• Intervention / Treatment: Device: Freedom SOLO Stentless 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.

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of Bristish Columbia St. Paul Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • St. Boniface Hospital
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • St. Vincent Heart Center
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Oakwood Hospital
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Toledo, Ohio, United States, 43606
      • The Toledo Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety will be determined by incidence rate of adverse events	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy will be determined by hemodynamics	The hemodynamic performance of the SOLO valve will be compared to that reported in the literature for other stentless bioprostheses and stented pericardial valves.	1 year
Effectiveness will be determined by NYHA Classification comparisons	Clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications.	1 year

Collaborators and Investigators

• Sponsor: Sorin Group USA, Inc.
• Investigators: 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: 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, University Laval; Principal Investigator: Jian Ye, MD, St. Paul'S Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (ESTIMATE): May 4, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 22, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Aortic; Valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: G100014