Trifecta Durability Study
This study is ongoing, but not recruiting participants.
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01256710
First received: December 7, 2010
Last updated: September 9, 2011
Last verified: September 2011
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Purpose
The purpose of the SJM International, Inc. sponsored "Trifecta™ Durability Study", is to evaluate the long-term durability of the Trifecta™ valve.
| Condition | Intervention |
|---|---|
|
Aortic Valve |
Device: Implantation of the Trifecta Valve |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Trifecta Durability Study |
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Actuarial freedom from reoperation due to Structural Valve Deterioration [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Actuarial survival rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Freedom from valve related death [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Freedom from structural valve deterioration [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 801 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2021 |
| Estimated Primary Completion Date: | June 2021 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Trifecta Valve Group |
Device: Implantation of the Trifecta Valve
Implantation of the bioprothesis valve, 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
Patients that are candicate for implantation or have been implanted over the past 9 months with a St. Jude Medical Trifecta heart valve.
Criteria
Inclusion Criteria:
- Patients implanted for less than 9 months, or candidate for implantation with a St Jude Medical Trifecta valve, as per current guidelines
- Patient requires aortic valve replacement.
- Patient is legal age in host country.
- Patients must be able and willing to provide written informed consent to participate in this investigation
- Patients must be willing and able to comply with all follow-up requirements
Exclusion Criteria:
- Patients with contraindication for cardiac surgery
- Patients who are pregnant.
- Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
- Patient has active endocarditis
- Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery.
- Patient is undergoing renal dialysis.
- Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
- Patient has a documented thrombus in left atrium or left ventricle.
- Patient had in the past mitral or tricuspid valve replacement.
- Patient needs mitral and/or tricuspid valve replacement.
- Patient has an Ejection Fraction < 25%
- Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted
- Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
- Patient has a life expectancy less than two years.
Contacts and Locations More Information
No publications provided
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01256710 History of Changes |
| Other Study ID Numbers: | CS-10-012-EU-TV |
| Study First Received: | December 7, 2010 |
| Last Updated: | September 9, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
ClinicalTrials.gov processed this record on May 16, 2013