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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

April 29, 2010
December 2, 2013
December 2010
June 2014   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01115907 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Freedom SOLO Stentless Heart Valve Study
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.

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

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Stenosis
  • Aortic Insufficiency
Device: Freedom SOLO Stentless Heart Valve
Freedom SOLO Stentless Heart Valve
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.
Intervention: Device: Freedom SOLO Stentless Heart Valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2017
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01115907
G100014
Yes
Sorin Group USA, Inc.
Sorin Group USA, Inc.
Not Provided
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
Sorin Group USA, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP