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The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.
The primary goal of the TV repair procedure is to relieve patients from TV insufficiency or reduce TV stenosis. This study will evaluate the hemodynamic efficacy of the Contour 3D® and Tri-Ad® ring and characterize the effect of the TV repair through assessment of right atrial size and right ventricular function. Additionally, this study will characterize the patient population for whom a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency. Health status and adverse events (AE) will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contour 3D® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure |
| |
| Tri-Ad® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contour 3D® implant for tricuspid valve repair | Device | Tricuspid annuloplasty ring |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Preimplant through Discharge |
| Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Preimplant through 6 Months |
| Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Preimplant through 12 Months |
| The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant | Discharge |
| The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Right Ventricle (RV) Diastolic Area | The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant. | Preimplant through Discharge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® or Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® or Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Vang | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Heart & Vascular Care at Aventura | Aventura | Florida | 33308 | United States | ||
| University of Michigan |
Not provided
| Label | URL |
|---|---|
| Sponsor website | View source |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Contour 3D® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring |
| FG001 | Tri-Ad® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Contour 3D® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Posted | Number | participants | Preimplant through Discharge |
|
Device or procedure related Adverse events (AEs) were collected from study enrollment to study closure, up to 1 year.
All new or worsening device or procedure related AEs were collected through1 year.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contour 3D® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shari Benoit | Medtronic Coronary and Structural Heart | (763) 514-4000 | 9749 | shari.g.benoit@medtronic.com |
Not provided
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
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| Tri-Ad® implant for tricuspid valve repair |
| Device |
Tricuspid annuloplasty ring |
|
| 6 months |
| The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant | 12 months |
| Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Preimplant through Discharge |
| Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Preimplant through 6 Months |
| Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Preimplant through 12 Months |
| Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant. | Preimplant through Discharge |
| Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant. | Preimplant through 6 Months |
| Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant | Preimplant through 12 Months |
| Change in the Right Ventricle (RV) Diastolic Area |
The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant. |
| Preimplant through 6 Months |
| Change in the Right Ventricle (RV) Diastolic Area | The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant | Preimplant through 12 Months |
| Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Preimplant through Discharge |
| Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Preimplant through 6 Months |
| Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Preimplant through 12 Months |
| Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Preimplant through Discharge |
| Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Preimplant through 6 Months |
| Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Preimplant through 12 Months |
| Demographic Data | Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status | Baseline |
| Change in New York Heart Association (NYHA) Classification | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Preimplant through Discharge |
| Change in New York Heart Association (NYHA) Classification | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Preimplant through 6 months |
| Change in New York Heart Association (NYHA) Classification . | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Preimplant through 12 months |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Mission Hospital Research Institute | Asheville | North Carolina | 28801 | United States |
| BG001 | Tri-Ad® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| OG001 | Tri-Ad® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring |
|
|
| Primary | Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Posted | Number | participants | Preimplant through 6 Months |
|
|
|
| Primary | Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Posted | Number | participants | Preimplant through 12 Months |
|
|
|
| Primary | The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant | Posted | Median | Inter-Quartile Range | mmHg | Discharge |
|
|
|
| Primary | The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant | Posted | Median | Inter-Quartile Range | mmHg | 6 months |
|
|
|
| Primary | The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant | Posted | Median | Inter-Quartile Range | mmHg | 12 months |
|
|
|
| Primary | Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Posted | Median | Inter-Quartile Range | mm | Preimplant through Discharge |
|
|
|
| Primary | Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Posted | Median | Inter-Quartile Range | mm | Preimplant through 6 Months |
|
|
|
| Primary | Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Posted | Median | Inter-Quartile Range | mm | Preimplant through 12 Months |
|
|
|
| Primary | Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant. | Posted | Median | Inter-Quartile Range | mm | Preimplant through Discharge |
|
|
|
| Primary | Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant. | Posted | Median | Inter-Quartile Range | mm | Preimplant through 6 Months |
|
|
|
| Primary | Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant | Posted | Median | Inter-Quartile Range | mm | Preimplant through 12 Months |
|
|
|
| Secondary | Change in the Right Ventricle (RV) Diastolic Area | The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant. | Posted | Median | Inter-Quartile Range | mm^2 | Preimplant through Discharge |
|
|
|
| Secondary | Change in the Right Ventricle (RV) Diastolic Area | The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant. | Posted | Median | Inter-Quartile Range | mm^2 | Preimplant through 6 Months |
|
|
|
| Secondary | Change in the Right Ventricle (RV) Diastolic Area | The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant | Posted | Median | Inter-Quartile Range | mm^2 | Preimplant through 12 Months |
|
|
|
| Secondary | Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Posted | Median | Inter-Quartile Range | mm | Preimplant through Discharge |
|
|
|
| Secondary | Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Posted | Median | Inter-Quartile Range | mm | Preimplant through 6 Months |
|
|
|
| Secondary | Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Posted | Median | Inter-Quartile Range | mm | Preimplant through 12 Months |
|
|
|
| Secondary | Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Posted | Median | Inter-Quartile Range | percent | Preimplant through Discharge |
|
|
|
| Secondary | Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Posted | Median | Inter-Quartile Range | percent | Preimplant through 6 Months |
|
|
|
| Secondary | Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Posted | Median | Inter-Quartile Range | percent | Preimplant through 12 Months |
|
|
|
| Secondary | Demographic Data | Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Change in New York Heart Association (NYHA) Classification | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Posted | Number | participants | Preimplant through Discharge |
|
|
|
| Secondary | Change in New York Heart Association (NYHA) Classification | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Posted | Number | participants | Preimplant through 6 months |
|
|
|
| Secondary | Change in New York Heart Association (NYHA) Classification . | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Posted | Number | participants | Preimplant through 12 months |
|
|
|
| 16 |
| 36 |
| 2 |
| 36 |
| EG001 | Tri-Ad® Implant | The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring | 10 | 28 | 0 | 28 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrioventricular block second degree | 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 embolism | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac output decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
| Worsened |
|
| Worsened |
|
| Previous CABG |
|
| CAD |
|
| CHF |
|
| Atrial Fibrillation/flutter |
|
| MI |
|
| Diabetes |
|
| Hypertension |
|
| Moderate or severe aortic valve insufficiency |
|
| Moderate or severe mitral valve insufficiency |
|
| Worsened |
|
| Worsened |
|
| Worsened |
|