Freedom SOLO Stentless Heart Valve Study

NCT01115907 | Completed Phase 3 DMC

• 1 other identifier: G100014
• Study Type: interventional
• Target: 251
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Aortic Stenosis; Aortic Insufficiency

Keywords

Aortic; Valve replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy will be determined by hemodynamics

  1 year

• Effectiveness will be determined by NYHA Classification comparisons

  1 year

Study Arms (1)

Freedom SOLO stentless valve implant

EXPERIMENTAL

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

Interventions

Freedom SOLO Stentless Heart Valve DEVICE

Freedom SOLO Stentless Heart Valve

Freedom SOLO stentless valve implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The subject has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
• 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.

Sponsors & Collaborators

• Sorin Group USA, Inc.: lead

Study Sites (15)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 46240, United States

Location

Oakwood Hospital

Dearborn, Michigan, 48124, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Bristish Columbia St. Paul Hospital

Vancouver, British Columbia, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• 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, University Laval

  PRINCIPAL INVESTIGATOR

• Jian Ye, MD

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 4, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

CA (6); US (9)