Freedom SOLO Stentless Heart Valve Study

Aortic Stenosis Clinical Trial

— SOLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115907
• Other study ID #: G100014
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2010
• Last updated: January 22, 2015
• Start date: December 2010
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Sorin Group USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Intervention

Device:
• Freedom SOLO Stentless Heart Valve
Freedom SOLO Stentless Heart Valve

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec
Canada	University of Bristish Columbia St. Paul Hospital	Vancouver	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba
United States	Emory University	Atlanta	Georgia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Oakwood Hospital	Dearborn	Michigan
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Valley Hospital	Ridgewood	New Jersey
United States	The Toledo Hospital	Toledo	Ohio
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sorin Group USA, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No