Clinical trial NCT01115907: Freedom SOLO Stentless Heart Valve Study
Official title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aortic Stenosis
Aortic Insufficiency
Keywords: Aortic
Valve replacement
Lead sponsor: Sorin Group USA, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety will be determined by incidence rate of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy will be determined by hemodynamics
timeFrame: 1 year
measure: Effectiveness will be determined by NYHA Classification comparisons
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Dearborn
country: United States
facility: Oakwood Hospital
state: Michigan
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: University of Bristish Columbia St. Paul Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
affiliation: The Cleveland Clinic
name: Eric Roselli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincent Heart Center
name: David Heimansohn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Valley Hospital
name: Alex Zapolanski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Vinod Thourani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oakwood Hospital
name: Reza Dabir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Ali Khoynezhad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Pranshanth Vallabhajosyula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Toledo Hospital
name: Michael Moront, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Main Line Health
name: Scott Goldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Shaohua Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Science Centre
name: L. Ray Guo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foothills Medical Center
name: Andrew Maitland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Boniface Hospital
name: Michael Moon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Pierre Voisine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Paul's Hospital
name: Jian Ye, MD
role: PRINCIPAL_INVESTIGATOR
References: