search
Back to results

Freedom SOLO Stentless Heart Valve Study (SOLO)

Primary Purpose

Aortic Stenosis, Aortic Insufficiency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Freedom SOLO Stentless Heart Valve
Sponsored by
Sorin Group USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Aortic, Valve replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical Center
  • Emory University
  • St. Vincent Heart Center
  • Oakwood Hospital
  • The Valley Hospital
  • Cleveland Clinic Foundation
  • The Toledo Hospital
  • Hospital of the University of Pennsylvania
  • Lankenau Medical Center
  • Foothills Medical Centre
  • University of Alberta Hospital
  • University of Bristish Columbia St. Paul Hospital
  • St. Boniface Hospital
  • London Health Sciences Centre
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Freedom SOLO stentless valve implant

Arm Description

Appropriate subjects will receive the Freedom SOLO stentless valve implant as a replacement for a diseased or damaged native or prosthetic aortic valve.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Effectiveness will be determined by NYHA Classification comparisons
Clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications.

Full Information

First Posted
April 29, 2010
Last Updated
January 22, 2015
Sponsor
Sorin Group USA, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01115907
Brief Title
Freedom SOLO Stentless Heart Valve Study
Acronym
SOLO
Official Title
Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorin Group USA, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Aortic Insufficiency
Keywords
Aortic, Valve replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Freedom SOLO stentless valve implant
Arm Type
Experimental
Arm Description
Appropriate subjects will receive the Freedom SOLO stentless valve implant as a replacement for a diseased or damaged native or prosthetic aortic valve.
Intervention Type
Device
Intervention Name(s)
Freedom SOLO Stentless Heart Valve
Intervention Description
Freedom SOLO Stentless Heart Valve
Primary Outcome Measure Information:
Title
Safety will be determined by incidence rate of adverse events
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Efficacy will be determined by hemodynamics
Description
The hemodynamic performance of the SOLO valve will be compared to that reported in the literature for other stentless bioprostheses and stented pericardial valves.
Time Frame
1 year
Title
Effectiveness will be determined by NYHA Classification comparisons
Description
Clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Roselli, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Heimansohn, MD
Organizational Affiliation
St. Vincent Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Zapolanski, MD
Organizational Affiliation
The Valley Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinod Thourani, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reza Dabir, MD
Organizational Affiliation
Oakwood Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Khoynezhad, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pranshanth Vallabhajosyula, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Moront, MD
Organizational Affiliation
The Toledo Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Goldman, MD
Organizational Affiliation
Main Line Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shaohua Wang, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
L. Ray Guo, MD
Organizational Affiliation
London Health Science Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Maitland, MD
Organizational Affiliation
Foothills Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Moon, MD
Organizational Affiliation
St. Boniface Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Voisine, MD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian Ye, MD
Organizational Affiliation
St. Paul's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
St. Vincent Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Oakwood Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Bristish Columbia St. Paul Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Freedom SOLO Stentless Heart Valve Study

We'll reach out to this number within 24 hrs