Trial Outcomes & Findings for EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty (NCT NCT01532921)
NCT ID: NCT01532921
Last Updated: 2018-08-10
Results Overview
The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant
Recruitment status
COMPLETED
Target enrollment
85 participants
Primary outcome timeframe
At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant
Results posted on
2018-08-10
Participant Flow
Participant milestones
| Measure |
Indicated for a TV Repair Procedure
All patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|
|
Overall Study
STARTED
|
85
|
|
Overall Study
Implantation Procedure
|
76
|
|
Overall Study
Discharge
|
75
|
|
Overall Study
6 Months Follow Up
|
68
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Indicated for a TV Repair Procedure
All patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Device was explanted during procedure
|
1
|
Baseline Characteristics
EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
Baseline characteristics by cohort
| Measure |
Indicated for a TV Repair Procedure
n=76 Participants
All patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
EuroSCORE II percentage score
|
8.7 percentage
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
NYHA Class
NYHA Class I
|
4 Participants
n=5 Participants
|
|
NYHA Class
NYHA Class II
|
23 Participants
n=5 Participants
|
|
NYHA Class
NYHA Class III
|
40 Participants
n=5 Participants
|
|
NYHA Class
NYHA Class IV
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implantPopulation: Implanted cohort
The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant
Outcome measures
| Measure |
Baseline
n=45 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
Discharge (up to 5 Days Post-implant)
n=57 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
6 Months Follow-Up
n=58 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|---|---|
|
Mean Gradient Across the Tricuspid Valve
|
1.3 mmHg
Standard Deviation 0.6
|
2.0 mmHg
Standard Deviation 1.0
|
1.9 mmHg
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implantPopulation: Implanted cohort
Change in the degree of tricuspid regurgitation measured via echocardiography from Baseline through 6 months post-implant. The severity of tricuspid regurgitation is graded by using several qualitative and quantitative methods. The degree of regurgitation is classified as "none", "Mild", "Moderate" or "Severe".
Outcome measures
| Measure |
Baseline
n=66 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
Discharge (up to 5 Days Post-implant)
n=65 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
6 Months Follow-Up
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|---|---|
|
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
Improved 4 grades
|
7 Participants
|
7 Participants
|
—
|
|
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
Improved 3 grades
|
8 Participants
|
10 Participants
|
—
|
|
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
Improved 2 grades
|
27 Participants
|
31 Participants
|
—
|
|
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
Improved 1 grade
|
21 Participants
|
16 Participants
|
—
|
|
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
No change
|
3 Participants
|
1 Participants
|
—
|
|
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
Worsened 2 grades
|
0 Participants
|
0 Participants
|
—
|
|
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
Worsened 3 grades
|
0 Participants
|
0 Participants
|
—
|
|
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
Worsened 4 grades
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implantPopulation: Implanted cohort
Change in the degree of TV leaflet coaptation length measured via echocardiography from Baseline through 6 months post-implant
Outcome measures
| Measure |
Baseline
n=39 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
Discharge (up to 5 Days Post-implant)
n=49 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
6 Months Follow-Up
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|---|---|
|
Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant
|
-0.6 mm
Standard Deviation 4.6
|
0.0 mm
Standard Deviation 5.1
|
—
|
PRIMARY outcome
Timeframe: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implantPopulation: Implanted cohort
Change in the degree of TV leaflet tethering height measured via echocardiography from Baseline through 6 months post-implant
Outcome measures
| Measure |
Baseline
n=39 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
Discharge (up to 5 Days Post-implant)
n=50 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
6 Months Follow-Up
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|---|---|
|
Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant
|
-0.2 mm
Standard Deviation 5.3
|
-0.5 mm
Standard Deviation 5.2
|
—
|
SECONDARY outcome
Timeframe: Basline to Discharge (up to 5 days post-implant) and 6 months post-implantPopulation: Implanted Cohort
Outcome measures
| Measure |
Baseline
n=36 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
Discharge (up to 5 Days Post-implant)
n=37 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
6 Months Follow-Up
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|---|---|
|
Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant
|
160.5 mm2
Standard Deviation 481.3
|
50.0 mm2
Standard Deviation 406.4
|
—
|
SECONDARY outcome
Timeframe: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implantPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implantPopulation: Implanted cohort
Outcome measures
| Measure |
Baseline
n=36 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
Discharge (up to 5 Days Post-implant)
n=37 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
6 Months Follow-Up
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|---|---|
|
Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant
|
1.7 percentage of change
Standard Deviation 13.4
|
-1.0 percentage of change
Standard Deviation 17.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implantPopulation: Implanted cohort
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. NYHA I implies no limitations. NYHA II implies slight limitation of physical activity. NYHA III implies marked limitation of physical activity and finally, NYHA IV implies patients are Unable to carry on any physical activity without discomfort.
Outcome measures
| Measure |
Baseline
n=13 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
Discharge (up to 5 Days Post-implant)
n=62 Participants
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
6 Months Follow-Up
All enrolled patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.
|
|---|---|---|---|
|
Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
Improved 3 classes
|
0 Participants
|
3 Participants
|
—
|
|
Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
Improved 2 classes
|
2 Participants
|
15 Participants
|
—
|
|
Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
Improved 1 class
|
6 Participants
|
28 Participants
|
—
|
|
Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
No change
|
4 Participants
|
13 Participants
|
—
|
|
Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
Worsened 1 class
|
1 Participants
|
3 Participants
|
—
|
|
Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
Worsened 2 classes
|
0 Participants
|
0 Participants
|
—
|
|
Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
Worsened 3 classes
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Adverse Events Within 6 Months of Implant Procedure
Serious events: 45 serious events
Other events: 46 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Adverse Events Within 6 Months of Implant Procedure
n=76 participants at risk
|
|---|---|
|
Cardiac disorders
Atrioventricular Block, Complete
|
13.2%
10/76 • Number of events 10 • 6 Months Follow-up period
|
|
Cardiac disorders
Pericardial Effusion
|
5.3%
4/76 • Number of events 4 • 6 Months Follow-up period
|
|
Renal and urinary disorders
Acute Kidney injury
|
6.6%
5/76 • Number of events 5 • 6 Months Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.6%
5/76 • Number of events 5 • 6 Months Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
11.8%
9/76 • Number of events 11 • 6 Months Follow-up period
|
|
Vascular disorders
Haemorrhage
|
15.8%
12/76 • Number of events 13 • 6 Months Follow-up period
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
2/76 • Number of events 2 • 6 Months Follow-up period
|
|
Cardiac disorders
Atrial Fibrillation
|
3.9%
3/76 • Number of events 3 • 6 Months Follow-up period
|
|
Cardiac disorders
Atrial Tachycardia
|
3.9%
3/76 • Number of events 3 • 6 Months Follow-up period
|
|
Cardiac disorders
Bradycardia
|
7.9%
6/76 • Number of events 6 • 6 Months Follow-up period
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.6%
2/76 • Number of events 2 • 6 Months Follow-up period
|
|
Cardiac disorders
Coronary Artery Occlusion
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Cardiac disorders
Mitral Valve Incompetence
|
2.6%
2/76 • Number of events 2 • 6 Months Follow-up period
|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Cardiac disorders
Sinus Node Dysfunction
|
2.6%
2/76 • Number of events 2 • 6 Months Follow-up period
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Congenital, familial and genetic disorders
Ventricular Septal Defect
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Eye disorders
Pupils Unequal
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
General disorders
Impaired Healing
|
1.3%
1/76 • Number of events 2 • 6 Months Follow-up period
|
|
General disorders
Multi-Organ Failure
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
General disorders
Pyrexia
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Infections and infestations
Bacterial Infection
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Infections and infestations
Endocarditis
|
2.6%
2/76 • Number of events 2 • 6 Months Follow-up period
|
|
Infections and infestations
Infection
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Infections and infestations
Mediastinitis
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Infections and infestations
Pneumonia
|
3.9%
3/76 • Number of events 3 • 6 Months Follow-up period
|
|
Infections and infestations
Respiratory Tract Infection
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Infections and infestations
Sepsis
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Infections and infestations
Septic Shock
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Injury, poisoning and procedural complications
Postoperative Thoracic Procedure Complication
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Injury, poisoning and procedural complications
Traumatic Lung Injury
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Investigations
Ejection Fraction Decreased
|
2.6%
2/76 • Number of events 2 • 6 Months Follow-up period
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Nervous system disorders
Syncope
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Psychiatric disorders
Psychotic disorder
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
|
Renal and urinary disorders
Renal Failure
|
3.9%
3/76 • Number of events 3 • 6 Months Follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/76 • Number of events 1 • 6 Months Follow-up period
|
Other adverse events
| Measure |
Adverse Events Within 6 Months of Implant Procedure
n=76 participants at risk
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
22.4%
17/76 • Number of events 17 • 6 Months Follow-up period
|
|
Surgical and medical procedures
Transfusion
|
5.3%
4/76 • Number of events 4 • 6 Months Follow-up period
|
|
Blood and lymphatic system disorders
Anaemia
|
14.5%
11/76 • Number of events 11 • 6 Months Follow-up period
|
|
Cardiac disorders
Atrial Fibrillation
|
10.5%
8/76 • Number of events 8 • 6 Months Follow-up period
|
|
Cardiac disorders
Pericardial Effusion
|
7.9%
6/76 • Number of events 6 • 6 Months Follow-up period
|
Additional Information
Ber Kleijnen
Medtronic, Bakken Research Center Coronary and Structural Heart Disease Management (CSH), Endepolsdomein 5, 6229 GW Maastricht, The Netherlands
Phone: +3143356 6566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60