An observational study in Tricuspid Valve Insufficiency, sponsored by Medtronic Bakken Research Center. Completed at 7 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-08-10.
Sponsored by Medtronic Bakken Research Center · Observational
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.
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.
219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.
This study's enrollment of 85 is below the median of 200 across 96 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Medtronic Bakken Research Center is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patient population includes 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. Patients with primary TV are not included, since this is often characterized by pathological leaflets for which the Contour 3D® Tricuspid Annuloplasty Ring would not be beneficial.
Exclusion Criteria:
All patients indicated for a Tricuspid Valve (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.
Procedure: Tricuspid valve repair · Procedure: Left-sided heart surgery · Device: Contour 3D Tricuspid Annuloplasty Ring
Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned
Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair
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
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
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
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
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
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
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
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
| Milestone | Indicated for a TV Repair Procedure |
|---|---|
| Started | 85 |
| Implantation procedure | 76 |
| Discharge | 75 |
| 6 months follow up | 68 |
| Completed | 69 |
| Not completed | 16 |
| Withdrew: Death | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Physician decision | 7 |
| Withdrew: Device was explanted during procedure | 1 |
The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant
| mmHg | Baseline | Discharge (up to 5 Days Post-implant) | 6 Months Follow-Up |
|---|---|---|---|
| Mean Gradient Across the Tricuspid Valve | 1.3 ± 0.6 | 2.0 ± 1.0 | 1.9 ± 0.9 |
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".
| Participants | Discharge (up to 5 Days Post-implant) | 6 Months Follow-Up |
|---|---|---|
| Improved 4 grades | 7 | 7 |
| Improved 3 grades | 8 | 10 |
| Improved 2 grades | 27 | 31 |
| Improved 1 grade | 21 | 16 |
| No change | 3 | 1 |
| Worsened 2 grades | 0 | 0 |
| Worsened 3 grades | 0 | 0 |
| Worsened 4 grades | 0 | 0 |
Change in the degree of TV leaflet coaptation length measured via echocardiography from Baseline through 6 months post-implant
| mm | Discharge (up to 5 Days Post-implant) | 6 Months Follow-Up |
|---|---|---|
| Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant | -0.6 ± 4.6 | 0.0 ± 5.1 |
Change in the degree of TV leaflet tethering height measured via echocardiography from Baseline through 6 months post-implant
| mm | Discharge (up to 5 Days Post-implant) | 6 Months Follow-Up |
|---|---|---|
| Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant | -0.2 ± 5.3 | -0.5 ± 5.2 |
| mm2 | Discharge (up to 5 Days Post-implant) | 6 Months Follow-Up |
|---|---|---|
| Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant | 160.5 ± 481.3 | 50.0 ± 406.4 |
No measurements were reported for this outcome.
| percentage of change | Discharge (up to 5 Days Post-implant) | 6 Months Follow-Up |
|---|---|---|
| Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant | 1.7 ± 13.4 | -1.0 ± 17.0 |
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.
| Participants | Discharge (up to 5 Days Post-implant) | 6 Months Follow-Up |
|---|---|---|
| Improved 3 classes | 0 | 3 |
| Improved 2 classes | 2 | 15 |
| Improved 1 class | 6 | 28 |
| No change | 4 | 13 |
| Worsened 1 class | 1 | 3 |
| Worsened 2 classes | 0 | 0 |
| Worsened 3 classes | 0 | 0 |
Collected over 6 Months Follow-up period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events Within 6 Months of Implant Procedure | 3/76 (3.9%) | 45/76 (59.2%) | 46/76 (60.5%) |
| Event | Adverse Events Within 6 Months of Implant Procedure |
|---|---|
| HaemorrhageVascular disorders | 12/76 |
| Atrioventricular Block, CompleteCardiac disorders | 10/76 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 9/76 |
| BradycardiaCardiac disorders | 6/76 |
| Acute Kidney injuryRenal and urinary disorders | 5/76 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 5/76 |
| Pericardial EffusionCardiac disorders | 4/76 |
| Atrial FibrillationCardiac disorders | 3/76 |
| Atrial TachycardiaCardiac disorders | 3/76 |
| PneumoniaInfections and infestations | 3/76 |
| Event | Adverse Events Within 6 Months of Implant Procedure |
|---|---|
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 17/76 |
| AnaemiaBlood and lymphatic system disorders | 11/76 |
| Atrial FibrillationCardiac disorders | 8/76 |
| Pericardial EffusionCardiac disorders | 6/76 |
| TransfusionSurgical and medical procedures | 4/76 |
Baseline data include all subjects who underwent the implant procedure of the study device
| Age, Continuous(years) | Indicated for a TV Repair Procedure |
|---|---|
| Mean | 72.2 ± 7.2 |
| Sex: Female, Male(Participants) | Indicated for a TV Repair Procedure |
|---|---|
| Female | 36 |
| Male | 40 |
| EuroSCORE II percentage score(percentage) | Indicated for a TV Repair Procedure |
|---|---|
| Mean | 8.7 ± 9.4 |
| NYHA Class(Participants) | Indicated for a TV Repair Procedure |
|---|---|
| NYHA Class I | 4 |
| NYHA Class II | 23 |
| NYHA Class III | 40 |
| NYHA Class IV | 9 |
Plan to share: No
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Tricuspid Valve Insufficiency→
Medtronic Bakken Research Center