Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Investigation of the Freedom SOLO Stentless Heart Valve

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT00876525
First received: April 3, 2009
Last updated: June 4, 2014
Last verified: June 2014

April 3, 2009
June 4, 2014
March 2009
December 2013   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00876525 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Clinical Investigation of the Freedom SOLO Stentless Heart Valve

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Valve Diseases
Device: Freedom SOLO
The Freedom SOLO heart valve prosthesis is a stentless bioprosthesis manufactured with bovine pericardium.
Experimental: Freedom SOLO stentless valve
Intervention: Device: Freedom SOLO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
700
September 2017
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Portugal,   Switzerland
 
NCT00876525
V10604
Yes
Sorin Group
Sorin Group
Not Provided
Principal Investigator: Markus Thalmann, MD KH Hietzing Wien
Sorin Group
June 2014

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