Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
This study is ongoing, but not recruiting participants.
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01514162
First received: January 17, 2012
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
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.
| Condition |
|---|
|
Subjects Who Were Previously Implanted With a Trifecta Valve. |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve |
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Primary Endpoint [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Report late adverse event rates
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Trifecta Valve Group
Subjects who were previously implanted with the Trifecta valve.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects who were previously implanted with the Trifecta valve.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514162
Locations
| United States, Minnesota | |
| Abbott Northwestern Hospital Cardiac Surgical Associates | |
| Minneapolis, Minnesota, United States, 55407 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, North Carolina | |
| Mission Hospital | |
| Asheville, North Carolina, United States, 28801 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Vanderbilt Heart Institute | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Utah | |
| Intermountain Heart & Lung Surgical Associates | |
| Murray, Utah, United States, 84157 | |
Sponsors and Collaborators
St. Jude Medical
More Information
No publications provided
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01514162 History of Changes |
| Other Study ID Numbers: | 1003 |
| Study First Received: | January 17, 2012 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by St. Jude Medical:
|
Trifecta Valve |
ClinicalTrials.gov processed this record on May 19, 2013