Freedom SOLO Stentless Heart Valve Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT01115907
First received: April 29, 2010
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Aortic Stenosis
Aortic Insufficiency
Device: Freedom SOLO Stentless Heart Valve
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America

Resource links provided by NLM:


Further study details as provided by Sorin Group USA, Inc.:

Primary Outcome Measures:
  • Safety will be determined by incidence rate of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Efficacy will be determined by hemodynamics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The hemodynamic performance of the SOLO valve will be compared to that reported in the literature for other stentless bioprostheses and stented pericardial valves.

  • Effectiveness will be determined by NYHA Classification comparisons [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications.


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115907

Locations
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
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
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: 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
  More Information

No publications provided

Responsible Party: Sorin Group USA, Inc.
ClinicalTrials.gov Identifier: NCT01115907     History of Changes
Other Study ID Numbers: G100014
Study First Received: April 29, 2010
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Sorin Group USA, Inc.:
Aortic
Valve replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014