Trifecta™ GT Post Market Clinical Follow-up

Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03016169

Enrollment

358

Registered

2017-01-10

Start date

2017-03-09

Completion date

2023-08-31

Last updated

2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Valve Disorder

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.

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.

Interventions

DEVICETrifecta GT (Glide Technology) Valve

Surgical aortic valve replacement with Trifecta GT Valve.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation	5 years post implant	Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.

Other

Measure	Time frame	Description
Freedom From Valve Related Mortality	5 years post implant	Estimated percentage of participants remaining free from a valve-related death at 5 years, using a Kaplan-Meier estimate. The estimate includes subjects alive at 5 years and subjects who died for reasons unrelated to the valve at 5 years.
Freedom From Structural Valve Deterioration	5 years post implant	Estimated percentage of participants free from structural valve deterioration at 5 years, as using a Kaplan-Meier estimate. Structural valve deterioration is any change in function of the valve resulting in an intrinsic abnormality of the valve that causes stenosis or regurgitation.
Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration	5 years post implant	Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate.
Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months	6 Months	LVEF is a measurement of the percentage of blood leaving the heart each time it contracts.
Freedom From All-cause Mortality	5 years post implant	Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate.
Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months	6 Months	iEOA adjusts the EOA measurement to the patient's body size.
Valve Hemodynamic Performance for Mean Gradient at Six Months	6 Months	Mean Gradient measures the average pressure difference across the valve during blood flow.
Valve Hemodynamic Performance for Peak Gradient at Six Months	6 Months	Peak Gradient measures the maximum pressure difference across the valve during blood flow.
Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months	6 Months	EOA measures the functional valve opening for blood flow through the valve.

Countries

Belgium, Canada, Estonia, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom, United States

Participant flow

Recruitment details

A total of 358 subjects were enrolled across 27 investigational sites in 12 North American and European countries. The Trifecta GT PMCF study is a single-arm, prospective, multi-center clinical investigation designed to evaluate the five-year safety and performance of the Trifecta GT valve in patients indicated for aortic valve replacement.

Participants by arm

Arm	Count
Treatment All subjects will receive the Trifecta GT valve Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.	358
Total	358

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	54
Overall Study	Device Explant	11
Overall Study	Lost to Follow-up	4
Overall Study	Other Reasons	1
Overall Study	Withdrawal by Subject	19

Baseline characteristics

Characteristic	Treatment	—
Age, Continuous	70.8 years STANDARD_DEVIATION 7.6	—
Hypertension	291 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	140 Participants	—
Sex: Female, Male Male	218 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	54 / 358
other Total, other adverse events	82 / 358
serious Total, serious adverse events	206 / 358

Outcome results

Primary

Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation

Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.