Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEContour 3D® implant for tricuspid valve repair
Tricuspid annuloplasty ring
DEVICETri-Ad® implant for tricuspid valve repair
Tricuspid annuloplasty ring
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subject or legal guardian willing and able to sign and date the Informed Consent Form (and Authorization to Use and Disclose Health Information Form, if applicable) * Subject indicated for a concomitant surgical repair of the TV * Subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred
Exclusion criteria
* Subject with a degenerative TV condition * Subject with primary TV regurgitation * Subject with a previous TV repair or replacement * Subject indicated for a stand-alone TV repair * Subject currently participating in an investigational drug or another device study * Subject with life expectancy of less than one year * Subject is pregnant or desires to be pregnant within 12 months following implantation * Subject is under 18 or over 85 years of age * Subject with active endocarditis * Subject with valvular retraction with severely reduced mobility * Subject with a heavily calcified TV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Degree of Tricuspid Regurgitation | Preimplant through Discharge | 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. |
| The Mean Gradient Across the Tricuspid Valve | Discharge | 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 |
| Change in the Degree of TV Leaflet Coaptation Length | Preimplant through Discharge | 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. |
| Change in the Degree of TV Leaflet Tethering Height | Preimplant through Discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in New York Heart Association (NYHA) Classification | Preimplant through Discharge | 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. |
| Change in the Right Ventricle (RV) Diastolic Area | Preimplant through Discharge | 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. |
| Change in New York Heart Association (NYHA) Classification . | Preimplant through 12 months | 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. |
| Change in the Tricuspid Annular (Basal) Diameter | Preimplant through Discharge | 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 |
| Change in the RV Fractional Area | Preimplant through Discharge | 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. |
| Demographic Data | Baseline | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| 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 | 28 |
| Total | 64 |
Baseline characteristics
| Characteristic | Contour 3D® Implant | Tri-Ad® Implant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 25 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 3 Participants | 16 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 11.6 | 73.7 years STANDARD_DEVIATION 8.5 | 70.7 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 21 Participants | 10 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 36 | 0 / 28 |
| serious Total, serious adverse events | 16 / 36 | 10 / 28 |
Outcome results
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.
Time frame: Preimplant through 6 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | Improved | 23 participants |
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | No Change | 6 participants |
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | Worsened | 1 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | Improved | 14 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | No Change | 4 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | Worsened | 2 participants |
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.
Time frame: Preimplant through Discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | Improved | 27 participants |
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | No Change | 6 participants |
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | Worsened | 2 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | Improved | 18 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | No Change | 6 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | Worsened | 1 participants |
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.
Time frame: Preimplant through 12 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | Improved | 17 participants |
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | No Change | 5 participants |
| Contour 3D® Implant | Change in the Degree of Tricuspid Regurgitation | Worsened | 3 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | Improved | 12 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | No Change | 7 participants |
| Tri-Ad® Implant | Change in the Degree of Tricuspid Regurgitation | Worsened | 1 participants |
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.
Time frame: Preimplant through Discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Degree of TV Leaflet Coaptation Length | 0.0 mm |
| Tri-Ad® Implant | Change in the Degree of TV Leaflet Coaptation Length | 0.0 mm |
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.
Time frame: Preimplant through 12 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Degree of TV Leaflet Coaptation Length | 0.0 mm |
| Tri-Ad® Implant | Change in the Degree of TV Leaflet Coaptation Length | 0.0 mm |
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.
Time frame: Preimplant through 6 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Degree of TV Leaflet Coaptation Length | 1.0 mm |
| Tri-Ad® Implant | Change in the Degree of TV Leaflet Coaptation Length | 0.0 mm |
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
Time frame: Preimplant through 12 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Degree of TV Leaflet Tethering Height | 1.0 mm |
| Tri-Ad® Implant | Change in the Degree of TV Leaflet Tethering Height | 1.0 mm |
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.
Time frame: Preimplant through Discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Degree of TV Leaflet Tethering Height | -0.8 mm |
| Tri-Ad® Implant | Change in the Degree of TV Leaflet Tethering Height | 0.5 mm |
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.
Time frame: Preimplant through 6 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Degree of TV Leaflet Tethering Height | 0.6 mm |
| Tri-Ad® Implant | Change in the Degree of TV Leaflet Tethering Height | 1.0 mm |
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
Time frame: Discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | The Mean Gradient Across the Tricuspid Valve | 2.2 mmHg |
| Tri-Ad® Implant | The Mean Gradient Across the Tricuspid Valve | 2.0 mmHg |
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
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | The Mean Gradient Across the Tricuspid Valve | 2.0 mmHg |
| Tri-Ad® Implant | The Mean Gradient Across the Tricuspid Valve | 2.0 mmHg |
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
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | The Mean Gradient Across the Tricuspid Valve | 2.0 mmHg |
| Tri-Ad® Implant | The Mean Gradient Across the Tricuspid Valve | 2.2 mmHg |
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.
Time frame: Preimplant through 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification | Improved | 20 participants |
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification | No Change | 8 participants |
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification | Worsened | 2 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification | Improved | 19 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification | No Change | 1 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification | Worsened | 1 participants |
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.
Time frame: Preimplant through Discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification | Improved | 19 participants |
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification | No Change | 13 participants |
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification | Worsened | 4 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification | Improved | 15 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification | No Change | 6 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification | Worsened | 5 participants |
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.
Time frame: Preimplant through 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification . | Improved | 19 participants |
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification . | No Change | 7 participants |
| Contour 3D® Implant | Change in New York Heart Association (NYHA) Classification . | Worsened | 0 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification . | Improved | 17 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification . | No Change | 3 participants |
| Tri-Ad® Implant | Change in New York Heart Association (NYHA) Classification . | Worsened | 1 participants |
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.
Time frame: Preimplant through Discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Right Ventricle (RV) Diastolic Area | -140.0 mm^2 |
| Tri-Ad® Implant | Change in the Right Ventricle (RV) Diastolic Area | 141.0 mm^2 |
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.
Time frame: Preimplant through 6 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Right Ventricle (RV) Diastolic Area | 160.5 mm^2 |
| Tri-Ad® Implant | Change in the Right Ventricle (RV) Diastolic Area | 70.6 mm^2 |
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
Time frame: Preimplant through 12 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Right Ventricle (RV) Diastolic Area | 395.0 mm^2 |
| Tri-Ad® Implant | Change in the Right Ventricle (RV) Diastolic Area | 211.0 mm^2 |
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.
Time frame: Preimplant through 6 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the RV Fractional Area | -0.8 percent |
| Tri-Ad® Implant | Change in the RV Fractional Area | -6.2 percent |
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.
Time frame: Preimplant through 12 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the RV Fractional Area | -0.4 percent |
| Tri-Ad® Implant | Change in the RV Fractional Area | -3.6 percent |
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.
Time frame: Preimplant through Discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the RV Fractional Area | -3.8 percent |
| Tri-Ad® Implant | Change in the RV Fractional Area | -1.8 percent |
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
Time frame: Preimplant through Discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Tricuspid Annular (Basal) Diameter | -4.0 mm |
| Tri-Ad® Implant | Change in the Tricuspid Annular (Basal) Diameter | 0.0 mm |
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
Time frame: Preimplant through 12 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Tricuspid Annular (Basal) Diameter | 4.0 mm |
| Tri-Ad® Implant | Change in the Tricuspid Annular (Basal) Diameter | 1.0 mm |
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
Time frame: Preimplant through 6 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Contour 3D® Implant | Change in the Tricuspid Annular (Basal) Diameter | 3.0 mm |
| Tri-Ad® Implant | Change in the Tricuspid Annular (Basal) Diameter | 1.0 mm |
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Contour 3D® Implant | Demographic Data | CAD | 12 participants |
| Contour 3D® Implant | Demographic Data | MI | 4 participants |
| Contour 3D® Implant | Demographic Data | Previous CABG | 6 participants |
| Contour 3D® Implant | Demographic Data | Diabetes | 11 participants |
| Contour 3D® Implant | Demographic Data | CHF | 19 participants |
| Contour 3D® Implant | Demographic Data | Hypertension | 27 participants |
| Contour 3D® Implant | Demographic Data | Previous Valve Replacement | 2 participants |
| Contour 3D® Implant | Demographic Data | Moderate or severe aortic valve insufficiency | 3 participants |
| Contour 3D® Implant | Demographic Data | Atrial Fibrillation/flutter | 22 participants |
| Contour 3D® Implant | Demographic Data | Moderate or severe mitral valve insufficiency | 31 participants |
| Contour 3D® Implant | Demographic Data | Previous Valve Repair | 5 participants |
| Tri-Ad® Implant | Demographic Data | Moderate or severe mitral valve insufficiency | 23 participants |
| Tri-Ad® Implant | Demographic Data | Previous Valve Repair | 1 participants |
| Tri-Ad® Implant | Demographic Data | Previous Valve Replacement | 3 participants |
| Tri-Ad® Implant | Demographic Data | Previous CABG | 5 participants |
| Tri-Ad® Implant | Demographic Data | CAD | 15 participants |
| Tri-Ad® Implant | Demographic Data | CHF | 13 participants |
| Tri-Ad® Implant | Demographic Data | Atrial Fibrillation/flutter | 18 participants |
| Tri-Ad® Implant | Demographic Data | MI | 4 participants |
| Tri-Ad® Implant | Demographic Data | Diabetes | 6 participants |
| Tri-Ad® Implant | Demographic Data | Hypertension | 24 participants |
| Tri-Ad® Implant | Demographic Data | Moderate or severe aortic valve insufficiency | 3 participants |