Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trifecta™ GT Post Market Clinical Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016169
Recruitment Status : Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Aortic Valve Disorder Device: Trifecta GT (Glide Technology) Valve Not Applicable

Detailed Description:

The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide.

Subjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)
Actual Study Start Date : March 9, 2017
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Treatment
All subjects will receive the Trifecta GT valve
Device: Trifecta GT (Glide Technology) Valve
Surgical aortic valve replacement with Trifecta GT Valve.




Primary Outcome Measures :
  1. Freedom from surgical valve replacement or transcatheter valve-in-valve implantation [ Time Frame: 5 years post implant ]
    Determined by adverse event reporting


Other Outcome Measures:
  1. Freedom from all-cause mortality [ Time Frame: 5 years post implant ]
    Determined by adverse event reporting

  2. Freedom from valve related mortality [ Time Frame: 5 years post implant ]
    Determined by adverse event reporting

  3. Freedom from structural valve deterioration [ Time Frame: 5 years post implant ]
    Determined by adverse event reporting

  4. Freedom from surgical valve replacement or transcatheter valve implantation due to structural valve deterioration [ Time Frame: 5 years post implant ]
    Determined by adverse event reporting

  5. Valve hemodynamic performance [ Time Frame: Up to 7 days, 6 months, 3 years and 5 years post implant ]
    Measured by echocardiogram



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.
  2. Subject is of legal age in the country where the subject is enrolled.
  3. Subject must be willing and able to provide written informed consent to participate in this study.
  4. Subject must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

  1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
  2. Subject has contraindication for cardiac surgery.
  3. Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
  4. Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).
  5. Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
  6. Subject is undergoing renal dialysis.
  7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
  8. Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
  9. Subject has a left ventricular ejection fraction < 30%.
  10. Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
  11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
  12. Subject has a life expectancy less than 2 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016169


Locations
Show Show 27 study locations
Sponsors and Collaborators
Abbott Medical Devices
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03016169    
Other Study ID Numbers: SJM-CIP-10120
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes