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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Tricuspid Valve Repair | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricuspid valve repair | Procedure |
| ||
| Left-sided heart surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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". | 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 | 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 | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rüdiger Lange, Prof. Dr. | Deutsches Herzzentrum München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de Lyon - Hôpital Louis Pradel | Lyon | 69500 | France | |||
| Centre Hospitalier de Mulhouse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30452076 | Derived | Guenzinger R, Lange RS, Riess FC, Hanke T, Bischoff N, Obadia JF, Sahar G, Bitran D, Roberts H Jr, Li S, Bolling SF. Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation. Thorac Cardiovasc Surg. 2020 Sep;68(6):478-485. doi: 10.1055/s-0038-1673665. Epub 2018 Nov 16. |
| Label | URL |
|---|---|
| Sponsor Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Procedure |
Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned |
|
| Contour 3D Tricuspid Annuloplasty Ring | Device | Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair |
|
| 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 | 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. | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant |
| Mulhouse |
| 68100 |
| France |
| Albertinen Herz- und Gefäßzentrum | Hamburg | 22457 | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | 23562 | Germany |
| Deutsches Herzzentrum München | Munich | D-80636 | Germany |
| Soroka Medical Center | Be'er Sheeva | 84101 | Israel |
| Shaare Zedek Medical Center | Jerusalem | Israel |
|
| Implantation Procedure | Subjects with study device implanted |
|
| Discharge |
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| 6 Months Follow Up |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline data include all subjects who underwent the implant procedure of the study device
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| EuroSCORE II percentage score | EuroSCORE II (European System for Cardiac Operative Risk Evaluation) is a risk model that allows the calculation of the risk of death after a heart operation. The higher the score, the higher the risk of death after surgery. The included risk factors are: age, gender, renal impairment, extracardiac arteriopathy, poor mobility, previous cardiac surgery, chronic lung disease, active endocarditis, critical preoperative state, diabetes on insulin, NYHA-class, CCS Class 4 Angina, Left ventricular function, recent myocardial infarction, pulmonary hypertension and 3 procedure-related factors. | Mean | Standard Deviation | percentage |
| ||||||||||||||||
| NYHA Class | 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. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Implanted cohort | Posted | Mean | Standard Deviation | mmHg | At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant |
|
|
| |||||||||||||||||||||||||||||||
| 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". | Implanted cohort | Posted | Count of Participants | Participants | Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant |
|
| |||||||||||||||||||||||||||||||||
| 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 | Implanted cohort | Posted | Mean | Standard Deviation | mm | Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant |
|
| ||||||||||||||||||||||||||||||||
| 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 | Implanted cohort | Posted | Mean | Standard Deviation | mm | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant | Implanted Cohort | Posted | Mean | Standard Deviation | mm2 | Basline to Discharge (up to 5 days post-implant) and 6 months post-implant |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant | Data were not collected | Posted | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant | Implanted cohort | Posted | Mean | Standard Deviation | percentage of change | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant |
|
| |||||||||||||||||||||||||||||||||
| 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. | Implanted cohort | Posted | Count of Participants | Participants | Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant |
|
6 Months Follow-up period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events Within 6 Months of Implant Procedure | 3 | 76 | 45 | 76 | 46 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Block, Complete | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Acute Kidney injury | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atrial Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Sinus Node Dysfunction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Ventricular Septal Defect | Congenital, familial and genetic disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pupils Unequal | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Retroperitoneal Haematoma | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Bacterial Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Postoperative Thoracic Procedure Complication | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Traumatic Lung Injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Transfusion | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ber Kleijnen | Medtronic, Bakken Research Center Coronary and Structural Heart Disease Management (CSH), Endepolsdomein 5, 6229 GW Maastricht, The Netherlands | +3143356 6566 | ber.kleijnen@medtronic.com |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| NYHA Class III |
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| NYHA Class IV |
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| Counts |
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