Tricuspid Valve Insufficiency
Conditions
Brief summary
Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment.
Detailed description
The EASE TRICUSPID Clinical Trial was a prospective, non-randomized, non-interventional, post-market release study. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment. Therefore, the primary objective of the EASE Tricuspid Study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring (Contour 3D ring) in subjects with tricuspid regurgitation who had a clinical indication for TV repair in a post-market use. Secondary objectives included the evaluation of the effect of TV repair with the Contour 3D ring on the right ventricular function, as well as the assessment of the effect of TV repair with the Contour 3D ring on the functional status in subjects undergoing TV repair in a post-market environment. Subjects eligible for TV repair and compliant with the enrollment criteria were considered by the Investigator for inclusion in the study. To minimize bias, enrolled subjects were followed by their own physician in accordance with the center's established practice for routine follow up. Follow-up sessions were planned at the physician's discretion. To meet the intended goals, appropriate clinical data were collected at baseline (pre-surgery), during the surgical procedure, at discharge and during the follow-up period at 6 months. Experienced echo-cardiologists evaluated the echos. At the time of enrollment it was not certain if the subject would receive a Contour 3D ring, since the surgeon might have decided during surgery that another treatment was more beneficial to the subject. In this case, the subject was terminated from the study.
Interventions
PROCEDURETricuspid valve repair
PROCEDURELeft-sided heart surgery
Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned
DEVICEContour 3D Tricuspid Annuloplasty Ring
Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Willing to sign and date the Patient Informed Consent (PIC) * Indicated for a concomitant surgical repair of the TV * Willing to return to the hospital, where the implantation originally occurred, for a 6 month follow-up visit
Exclusion criteria
* Patients with a degenerative TV condition * Patients with primary TV regurgitation * Previous TV repair or replacement * Stand-alone TV repair * Already participating in another investigational device or drug study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints * Life expectancy of less than one year * Pregnant or desire to be pregnant within 12 months of the study treatment * Under 18 years or over 85 years of age * Patients with active endocarditis * Patients with valvular retraction with severely reduced mobility * Patients with a heavily calcified TV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant | Change in the degree of TV leaflet tethering height measured via echocardiography from Baseline through 6 months post-implant |
| Mean Gradient Across the Tricuspid Valve | At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant | The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant |
| Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant | Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant | 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. |
| Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant | Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant | Change in the degree of TV leaflet coaptation length measured via echocardiography from Baseline through 6 months post-implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant | Basline to Discharge (up to 5 days post-implant) and 6 months post-implant | — |
| Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant | — |
| Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant | — |
| Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant | 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. |
Countries
France, Germany, Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Device was explanted during procedure | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Indicated for a TV Repair Procedure |
|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 7.2 |
| EuroSCORE II percentage score | 8.7 percentage STANDARD_DEVIATION 9.4 |
| NYHA Class NYHA Class I | 4 Participants |
| NYHA Class NYHA Class II | 23 Participants |
| NYHA Class NYHA Class III | 40 Participants |
| NYHA Class NYHA Class IV | 9 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 76 |
| other Total, other adverse events | 46 / 76 |
| serious Total, serious adverse events | 45 / 76 |
Outcome results
Primary
Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
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.
Time frame: Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant
Population: Implanted cohort
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline | 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 |
| Baseline | 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 |
| Baseline | 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 |
| Baseline | 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 |
| Baseline | 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 |
| Baseline | 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 |
| Baseline | 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 |
| Baseline | 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 |
| Discharge (up to 5 Days Post-implant) | 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 |
| Discharge (up to 5 Days Post-implant) | 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 |
| Discharge (up to 5 Days Post-implant) | 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 | 10 Participants |
| Discharge (up to 5 Days Post-implant) | 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 | 31 Participants |
| Discharge (up to 5 Days Post-implant) | 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 | 16 Participants |
| Discharge (up to 5 Days Post-implant) | Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant | No change | 1 Participants |
| Discharge (up to 5 Days Post-implant) | 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 |
| Discharge (up to 5 Days Post-implant) | 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 |
Primary
Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant
Change in the degree of TV leaflet tethering height measured via echocardiography from Baseline through 6 months post-implant
Time frame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Population: Implanted cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | 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 |
| Discharge (up to 5 Days Post-implant) | Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant | -0.5 mm | Standard Deviation 5.2 |
Primary
Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant
Change in the degree of TV leaflet coaptation length measured via echocardiography from Baseline through 6 months post-implant
Time frame: Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant
Population: Implanted cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant | -0.6 mm | Standard Deviation 4.6 |
| Discharge (up to 5 Days Post-implant) | Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant | 0.0 mm | Standard Deviation 5.1 |
Primary
Mean Gradient Across the Tricuspid Valve
The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant
Time frame: At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant
Population: Implanted cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Mean Gradient Across the Tricuspid Valve | 1.3 mmHg | Standard Deviation 0.6 |
| Discharge (up to 5 Days Post-implant) | Mean Gradient Across the Tricuspid Valve | 2.0 mmHg | Standard Deviation 1 |
| 6 Months Follow-Up | Mean Gradient Across the Tricuspid Valve | 1.9 mmHg | Standard Deviation 0.9 |
Secondary
Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
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.
Time frame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Population: Implanted cohort
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Worsened 2 classes | 0 Participants |
| Baseline | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Worsened 3 classes | 0 Participants |
| Baseline | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Improved 3 classes | 0 Participants |
| Baseline | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Improved 2 classes | 2 Participants |
| Baseline | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Improved 1 class | 6 Participants |
| Baseline | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | No change | 4 Participants |
| Baseline | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Worsened 1 class | 1 Participants |
| Discharge (up to 5 Days Post-implant) | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Improved 1 class | 28 Participants |
| Discharge (up to 5 Days Post-implant) | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Worsened 1 class | 3 Participants |
| Discharge (up to 5 Days Post-implant) | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Worsened 2 classes | 0 Participants |
| Discharge (up to 5 Days Post-implant) | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Improved 2 classes | 15 Participants |
| Discharge (up to 5 Days Post-implant) | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Worsened 3 classes | 0 Participants |
| Discharge (up to 5 Days Post-implant) | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | No change | 13 Participants |
| Discharge (up to 5 Days Post-implant) | Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant | Improved 3 classes | 3 Participants |
Secondary
Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant
Time frame: Basline to Discharge (up to 5 days post-implant) and 6 months post-implant
Population: Implanted Cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant | 160.5 mm2 | Standard Deviation 481.3 |
| Discharge (up to 5 Days Post-implant) | Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant | 50.0 mm2 | Standard Deviation 406.4 |
Secondary
Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant
Time frame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Population: Implanted cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant | 1.7 percentage of change | Standard Deviation 13.4 |
| Discharge (up to 5 Days Post-implant) | Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant | -1.0 percentage of change | Standard Deviation 17 |
Secondary
Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant
Time frame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Population: Data were not collected