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Long Term Follow Up Study of the St. Jude Medical Trifecta Valve

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01593917
First received: May 4, 2012
Last updated: October 14, 2016
Last verified: October 2016

May 4, 2012
October 14, 2016
June 2012
April 2020   (final data collection date for primary outcome measure)
Collecting long term valve related events [ Time Frame: 10 years ] [ Designated as safety issue: No ]
The primary objective is to collect long-term study data including long term valve-related events of the Trifecta valve
Same as current
Complete list of historical versions of study NCT01593917 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Long Term Follow Up Study of the St. Jude Medical Trifecta Valve
Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve
To collect long term follow up study data of the Trifecta valve in subjects who 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 previously implanted with a Trifecta prosthetic valve
  • Aortic Valve Insufficiency
  • Aortic Valve Regurgitation
  • Aortic Valve Stenosis
  • Aortic Valve Incompetence
Not Provided
Subjects previously implanted with a Trifecta valve
Subjects enrolled in this clinical study received the Trifecta valve during the investigational study that was conducted to obtain FDA approval
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
650
April 2020
April 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient currently has a Trifecta valve that was implanted
  • Patient met eligibility criteria prior to enrollment in the Trifecta IDE study
  • Patient agrees to complete all required follow-up visits
  • Patient provided written informed consent prior to any study related procedure as approved by the governing Institutional Review Board or the Ethics Committee of the investigational site

Exclusion Criteria:

  • Patient is currently participating or planning to participate in any other study unless approved by SJM
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01593917
1104
Yes
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Study Director: Angie Roach St. Jude Medical
St. Jude Medical
October 2016

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