Trial Outcomes & Findings for Trifecta™ GT Post Market Clinical Follow-up (NCT NCT03016169)
NCT ID: NCT03016169
Last Updated: 2025-02-11
Results Overview
Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
358 participants
Primary outcome timeframe
5 years post implant
Results posted on
2025-02-11
Participant Flow
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.
Participant milestones
| Measure |
Treatment
All subjects will receive the Trifecta GT valve.
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Overall Study
STARTED
|
358
|
|
Overall Study
COMPLETED
|
269
|
|
Overall Study
NOT COMPLETED
|
89
|
Reasons for withdrawal
| Measure |
Treatment
All subjects will receive the Trifecta GT valve.
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Death
|
54
|
|
Overall Study
Device Explant
|
11
|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Other Reasons
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=358 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 7.6 • n=358 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=358 Participants
|
|
Sex: Female, Male
Male
|
218 Participants
n=358 Participants
|
|
Hypertension
|
291 Participants
n=358 Participants
|
PRIMARY outcome
Timeframe: 5 years post implantPopulation: Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018.
Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.
Outcome measures
| Measure |
Treatment
n=358 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation
|
95.8 percentage of participants
Interval 92.8 to 97.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 years post implantPopulation: Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018
Estimated percentage of participants surviving at 5 years, using a Kaplan-Meier estimate.
Outcome measures
| Measure |
Treatment
n=358 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Freedom From All-cause Mortality
|
84.5 percentage of participants
Interval 80.2 to 88.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 years post implantPopulation: Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018.
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.
Outcome measures
| Measure |
Treatment
n=358 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Freedom From Valve Related Mortality
|
95.4 percentage of participants
Interval 92.3 to 97.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 years post implantPopulation: Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018.
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.
Outcome measures
| Measure |
Treatment
n=358 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Freedom From Structural Valve Deterioration
|
96.2 percentage of participants
Interval 93.3 to 97.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 years post implantPopulation: Analysis population includes participants implanted with the Trifecta™ valve in the study on 10 March 2017 and continued through 05 February 2018.
Estimated percentage of participants who do not require surgery due to structural valve deterioration, using a Kaplan-Meier estimate.
Outcome measures
| Measure |
Treatment
n=358 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Freedom From Surgical Valve Replacement or Transcatheter Valve Implantation Due to Structural Valve Deterioration
|
98.2 percentage of participants
Interval 95.8 to 99.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Analysis population includes all study participants with an LVEF assessment at 6 months.
LVEF is a measurement of the percentage of blood leaving the heart each time it contracts.
Outcome measures
| Measure |
Treatment
n=234 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Valve Hemodynamic Performance for Left Ventricular Ejection Fraction (LVEF) at Six Months
|
60.4 percentage
Standard Deviation 7.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Analysis population includes all study participants with an EOA assessment at 6 months.
EOA measures the functional valve opening for blood flow through the valve.
Outcome measures
| Measure |
Treatment
n=285 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Valve Hemodynamic Performance for Effective Orifice Area (EOA) at Six Months
|
2.0 cm^2
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Analysis population includes all study participants with an iEOA assessment at 6 months.
iEOA adjusts the EOA measurement to the patient's body size.
Outcome measures
| Measure |
Treatment
n=265 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Valve Hemodynamic Performance for Indexed Effective Orifice Area (iEOA) at Six Months
|
1.0 cm^2/m^2
Standard Deviation 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Analysis population includes all study participants with a mean gradient assessment at 6 months.
Mean Gradient measures the average pressure difference across the valve during blood flow.
Outcome measures
| Measure |
Treatment
n=303 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Valve Hemodynamic Performance for Mean Gradient at Six Months
|
8.7 mmHg
Standard Deviation 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsPopulation: Analysis population includes all study participants with a peak gradient assessment at 6 months.
Peak Gradient measures the maximum pressure difference across the valve during blood flow.
Outcome measures
| Measure |
Treatment
n=302 Participants
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Valve Hemodynamic Performance for Peak Gradient at Six Months
|
16.6 mmHg
Standard Deviation 6.3
|
Adverse Events
Treatment
Serious events: 206 serious events
Other events: 82 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Treatment
n=358 participants at risk
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Blood and lymphatic system disorders
MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Blood and lymphatic system disorders
MAJOR BLEEDING - OTHER BLEEDING
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Blood and lymphatic system disorders
OTHER CARDIOVASCULAR
|
3.4%
12/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Blood and lymphatic system disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
2.0%
7/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
EMBOLISM
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
ENDOCARDITIS
|
2.2%
8/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
NONSTRUCTURAL DYSFUNCTION
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
OTHER CARDIOVASCULAR
|
23.2%
83/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
STRUCTURAL VALVE DETERIORATION
|
2.2%
8/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Ear and labyrinth disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Endocrine disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Eye disorders
OTHER NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Eye disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
1.1%
4/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Gastrointestinal disorders
MAJOR BLEEDING - GASTROINTESTINAL BLEED
|
1.1%
4/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Gastrointestinal disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
4.7%
17/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
General disorders
OTHER CARDIOVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
General disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
3.1%
11/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Hepatobiliary disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
2.0%
7/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Infections and infestations
ENDOCARDITIS
|
2.2%
8/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Infections and infestations
OTHER CARDIOVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Infections and infestations
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
10.1%
36/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Injury, poisoning and procedural complications
MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Injury, poisoning and procedural complications
MAJOR BLEEDING - OTHER BLEEDING
|
1.1%
4/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Injury, poisoning and procedural complications
OTHER CARDIOVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Injury, poisoning and procedural complications
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
1.7%
6/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Metabolism and nutrition disorders
OTHER CARDIOVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Metabolism and nutrition disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
2.5%
9/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Musculoskeletal and connective tissue disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
4.5%
16/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OTHER NEUROVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
7.3%
26/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Nervous system disorders
EMBOLISM
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Nervous system disorders
MAJOR BLEEDING - OTHER BLEEDING
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Nervous system disorders
OTHER CARDIOVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Nervous system disorders
OTHER NEUROVASCULAR
|
5.6%
20/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Nervous system disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
1.4%
5/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Psychiatric disorders
OTHER NEUROVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Psychiatric disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
1.1%
4/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Renal and urinary disorders
MAJOR BLEEDING - UROLOGIC BLEEDING
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Renal and urinary disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
5.0%
18/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Reproductive system and breast disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Respiratory, thoracic and mediastinal disorders
MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Respiratory, thoracic and mediastinal disorders
OTHER CARDIOVASCULAR
|
2.5%
9/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Respiratory, thoracic and mediastinal disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
8.7%
31/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Skin and subcutaneous tissue disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Social circumstances
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Surgical and medical procedures
MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Surgical and medical procedures
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
1.1%
4/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Vascular disorders
EMBOLISM
|
2.5%
9/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Vascular disorders
MAJOR BLEEDING - MEDIASTINAL OR THORACIC BLEED
|
1.1%
4/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Vascular disorders
MAJOR BLEEDING - OTHER BLEEDING
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Vascular disorders
OTHER CARDIOVASCULAR
|
2.0%
7/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Vascular disorders
OTHER NEUROVASCULAR
|
1.1%
4/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Vascular disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
1.7%
6/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
Other adverse events
| Measure |
Treatment
n=358 participants at risk
All subjects will receive the Trifecta GT valve
Trifecta GT (Glide Technology) Valve: Surgical aortic valve replacement with Trifecta GT Valve.
|
|---|---|
|
Blood and lymphatic system disorders
OTHER CARDIOVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Blood and lymphatic system disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
NONSTRUCTURAL DYSFUNCTION
|
1.4%
5/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
OTHER CARDIOVASCULAR
|
11.7%
42/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Cardiac disorders
STRUCTURAL VALVE DETERIORATION
|
1.1%
4/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Eye disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Gastrointestinal disorders
MAJOR BLEEDING - GASTROINTESTINAL BLEED
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Gastrointestinal disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
General disorders
OTHER CARDIOVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
General disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Infections and infestations
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Metabolism and nutrition disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Musculoskeletal and connective tissue disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Nervous system disorders
EMBOLISM
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Nervous system disorders
OTHER NEUROVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Nervous system disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Product Issues
NONSTRUCTURAL DYSFUNCTION
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Product Issues
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Psychiatric disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Renal and urinary disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Respiratory, thoracic and mediastinal disorders
MAJOR BLEEDING - OTHER BLEEDING
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Respiratory, thoracic and mediastinal disorders
OTHER CARDIOVASCULAR
|
0.28%
1/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Respiratory, thoracic and mediastinal disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
2.2%
8/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Skin and subcutaneous tissue disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.84%
3/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Vascular disorders
OTHER CARDIOVASCULAR
|
2.2%
8/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
|
Vascular disorders
OTHER NON-CARDIOVASCULAR/NON-NEUROVASCULAR
|
0.56%
2/358 • 5 Years
All AEs reported in the Trifecta GT PMCF study.
|
Additional Information
Karine Miquel, Associate Director of Project Management
Abbott
Phone: +32 479 600 107
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may not publish study results until publication of results of multi center study or 2 years after study completion, whichever is sooner. PI allows Sponsor to review any proposed publication at least 40 days before forwarding it to any person that is not bound by confidentiality agreement between Sponsor and PI. Sponsor can request delay publication for no more than 120 days to allow Sponsor to file patent applications or take other measures to preserve or secure its Intellectual Property.
- Publication restrictions are in place
Restriction type: OTHER