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Clinical Investigation of the Freedom SOLO Stentless Heart Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00876525
Recruitment Status : Unknown
Verified November 2016 by LivaNova.
Recruitment status was:  Active, not recruiting
First Posted : April 6, 2009
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
LivaNova

Tracking Information
First Submitted Date  ICMJE April 3, 2009
First Posted Date  ICMJE April 6, 2009
Last Update Posted Date December 1, 2016
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2009)
The complication and survival rates for the Freedom SOLO stentless valve. [ Time Frame: Preoperatively, at implant, early postoperative, late postoperative, 1 year, annually until study completion. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00876525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2009)
Hemodynamic performance of the Freedom SOLO stentless valve. Clinically significant improvement in overall patient condition. [ Time Frame: Preoperatively, at implant, early postoperative, late postoperative, 1 year, annually until study completion. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Official Title  ICMJE Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Brief Summary This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Valve Diseases
Intervention  ICMJE Device: Freedom SOLO
The Freedom SOLO heart valve prosthesis is a stentless bioprosthesis manufactured with bovine pericardium.
Study Arms Experimental: Freedom SOLO stentless valve
Intervention: Device: Freedom SOLO
Publications * Thalmann M, Grubitzsch H, Matschke K, Glauber M, Tan E, Francois K, Amorim MJ, Hensens AG, Cesari F, Feyrer R, Diegeler A, Veit F, Repossini A; Freedom Solo Investigators. A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis. Ann Thorac Surg. 2016 Jan;101(1):100-8. doi: 10.1016/j.athoracsur.2015.06.096. Epub 2015 Oct 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 3, 2009)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date September 2017
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient is male or female 18 years old or older.
  • The patient is willing to sign the informed consent.
  • The patient which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
  • Any patient 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 patient 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).
  • Patient will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion Criteria:

  • The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
  • The patient requires a double or triple valve replacement (a valve repair is not considered an exclusion criterion).
  • The patient has a previously implanted SOLO valve, within the clinical study, that requires replacement.
  • The patient has active endocarditis.
  • The patient is or will be participating in a concomitant research study of an investigational product.
  • The patient is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.
  • The patient 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 patient.
  • The patient is pregnant or lactating.
  • Patients with congenital bicuspid aortic valve.
  • Patients are known to be noncompliant or are unlikely to complete the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Portugal,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00876525
Other Study ID Numbers  ICMJE V10604
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party LivaNova
Study Sponsor  ICMJE LivaNova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Markus Thalmann, MD KH Hietzing Wien
PRS Account LivaNova
Verification Date November 2016

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