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

Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01514162
First received: January 17, 2012
Last updated: August 7, 2014
Last verified: August 2014

January 17, 2012
August 7, 2014
February 2012
October 2014   (final data collection date for primary outcome measure)
Primary Endpoint [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Report late adverse event rates
Same as current
Complete list of historical versions of study NCT01514162 on ClinicalTrials.gov Archive Site
  • Secondary Endpoint [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To report subject NYHA functional classification status
  • Secondary Endpoint [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To report the hemodynamic performance of the valve, as per echocardiography
Same as current
Not Provided
Not Provided
 
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who have had the Trifecta valve implanted during the IDE study.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects who were previously implanted with the Trifecta valve.

Subjects Who Were Previously Implanted With a Trifecta Valve.
Not Provided
Trifecta Valve Group
Subjects who were previously implanted with the Trifecta valve.
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
300
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who were previously implanted with the Trifecta valve at one of the US sites of the IDE study.
  • Subject met eligibility criteria of IDE study
  • Subject agrees to complete study follow-up visits
  • Subject provided written informed consent

Exclusion Criteria:

  • Subject currently participating in another device or drug study
  • Subject unable or unwilling to return for study follow-up visits
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01514162
1003
No
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
August 2014

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