Trial Outcomes & Findings for Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial (NCT NCT01585779)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

64 participants

Primary outcome timeframe

Preimplant through Discharge

Results posted on

2017-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	36	28
Overall Study COMPLETED	26	21
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contour 3D® Implant n=36 Participants 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	Tri-Ad® Implant n=28 Participants 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	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Age, Continuous	68.4 years STANDARD_DEVIATION 11.6 • n=5 Participants	73.7 years STANDARD_DEVIATION 8.5 • n=7 Participants	70.7 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=35 Participants 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	Tri-Ad® Implant n=25 Participants 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
Change in the Degree of Tricuspid Regurgitation Improved	27 participants	18 participants
Change in the Degree of Tricuspid Regurgitation No Change	6 participants	6 participants
Change in the Degree of Tricuspid Regurgitation Worsened	2 participants	1 participants

PRIMARY outcome

Timeframe: Preimplant through 6 Months

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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=30 Participants 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	Tri-Ad® Implant n=20 Participants 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
Change in the Degree of Tricuspid Regurgitation Improved	23 participants	14 participants
Change in the Degree of Tricuspid Regurgitation No Change	6 participants	4 participants
Change in the Degree of Tricuspid Regurgitation Worsened	1 participants	2 participants

PRIMARY outcome

Timeframe: Preimplant through 12 Months

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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=25 Participants 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	Tri-Ad® Implant n=20 Participants 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
Change in the Degree of Tricuspid Regurgitation Improved	17 participants	12 participants
Change in the Degree of Tricuspid Regurgitation No Change	5 participants	7 participants
Change in the Degree of Tricuspid Regurgitation Worsened	3 participants	1 participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=35 Participants 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	Tri-Ad® Implant n=26 Participants 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
The Mean Gradient Across the Tricuspid Valve	2.2 mmHg Interval 1.9 to 3.0	2.0 mmHg Interval 2.0 to 3.0

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=30 Participants 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	Tri-Ad® Implant n=20 Participants 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
The Mean Gradient Across the Tricuspid Valve	2.0 mmHg Interval 1.3 to 3.0	2.2 mmHg Interval 1.6 to 3.0

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=25 Participants 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	Tri-Ad® Implant n=21 Participants 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
The Mean Gradient Across the Tricuspid Valve	2.0 mmHg Interval 1.9 to 3.0	2.0 mmHg Interval 1.0 to 2.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=34 Participants 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	Tri-Ad® Implant n=24 Participants 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
Change in the Degree of TV Leaflet Coaptation Length	0.0 mm Interval -2.9 to 2.0	0.0 mm Interval -1.0 to 1.8

PRIMARY outcome

Timeframe: Preimplant through 6 Months

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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=29 Participants 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	Tri-Ad® Implant n=19 Participants 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
Change in the Degree of TV Leaflet Coaptation Length	1.0 mm Interval -1.0 to 2.0	0.0 mm Interval -2.1 to 1.0

PRIMARY outcome

Timeframe: Preimplant through 12 Months

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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=25 Participants 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	Tri-Ad® Implant n=20 Participants 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
Change in the Degree of TV Leaflet Coaptation Length	0.0 mm Interval -2.0 to 1.0	0.0 mm Interval -2.1 to 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=34 Participants 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	Tri-Ad® Implant n=24 Participants 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
Change in the Degree of TV Leaflet Tethering Height	-0.8 mm Interval -2.0 to 1.0	0.5 mm Interval -0.6 to 2.0

PRIMARY outcome

Timeframe: Preimplant through 6 Months

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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=29 Participants 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	Tri-Ad® Implant n=19 Participants 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
Change in the Degree of TV Leaflet Tethering Height	0.6 mm Interval -2.0 to 3.0	1.0 mm Interval -1.0 to 2.0

PRIMARY outcome

Timeframe: Preimplant through 12 Months

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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=25 Participants 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	Tri-Ad® Implant n=20 Participants 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
Change in the Degree of TV Leaflet Tethering Height	1.0 mm Interval -1.0 to 2.5	1.0 mm Interval -2.7 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=31 Participants 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	Tri-Ad® Implant n=22 Participants 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
Change in the Right Ventricle (RV) Diastolic Area	-140.0 mm^2 Interval -585.0 to 61.0	141.0 mm^2 Interval -492.0 to 561.0

SECONDARY outcome

Timeframe: Preimplant through 6 Months

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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=28 Participants 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	Tri-Ad® Implant n=17 Participants 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
Change in the Right Ventricle (RV) Diastolic Area	160.5 mm^2 Interval -155.0 to 451.0	70.6 mm^2 Interval -374.0 to 499.0

SECONDARY outcome

Timeframe: Preimplant through 12 Months

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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=24 Participants 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	Tri-Ad® Implant n=18 Participants 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
Change in the Right Ventricle (RV) Diastolic Area	395.0 mm^2 Interval -12.5 to 626.5	211.0 mm^2 Interval -174.0 to 550.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=34 Participants 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	Tri-Ad® Implant n=23 Participants 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
Change in the Tricuspid Annular (Basal) Diameter	-4.0 mm Interval -6.0 to 2.0	0.0 mm Interval -4.0 to 6.0

SECONDARY outcome

Timeframe: Preimplant through 6 Months

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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=29 Participants 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	Tri-Ad® Implant n=18 Participants 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
Change in the Tricuspid Annular (Basal) Diameter	3.0 mm Interval -4.0 to 7.0	1.0 mm Interval -8.0 to 6.0

SECONDARY outcome

Timeframe: Preimplant through 12 Months

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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=25 Participants 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	Tri-Ad® Implant n=19 Participants 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
Change in the Tricuspid Annular (Basal) Diameter	4.0 mm Interval -2.0 to 7.0	1.0 mm Interval -6.0 to 11.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=31 Participants 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	Tri-Ad® Implant n=22 Participants 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
Change in the RV Fractional Area	-3.8 percent Interval -15.6 to 4.0	-1.8 percent Interval -14.3 to 11.8

SECONDARY outcome

Timeframe: Preimplant through 6 Months

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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=28 Participants 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	Tri-Ad® Implant n=17 Participants 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
Change in the RV Fractional Area	-0.8 percent Interval -10.0 to 7.2	-6.2 percent Interval -12.9 to 3.8

SECONDARY outcome

Timeframe: Preimplant through 12 Months

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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=24 Participants 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	Tri-Ad® Implant n=18 Participants 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
Change in the RV Fractional Area	-0.4 percent Interval -12.2 to 7.9	-3.6 percent Interval -13.4 to 0.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=36 Participants 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	Tri-Ad® Implant n=28 Participants 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
Demographic Data Previous Valve Repair	5 participants	1 participants
Demographic Data Previous Valve Replacement	2 participants	3 participants
Demographic Data Previous CABG	6 participants	5 participants
Demographic Data CAD	12 participants	15 participants
Demographic Data CHF	19 participants	13 participants
Demographic Data Atrial Fibrillation/flutter	22 participants	18 participants
Demographic Data MI	4 participants	4 participants
Demographic Data Diabetes	11 participants	6 participants
Demographic Data Hypertension	27 participants	24 participants
Demographic Data Moderate or severe aortic valve insufficiency	3 participants	3 participants
Demographic Data Moderate or severe mitral valve insufficiency	31 participants	23 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=36 Participants 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	Tri-Ad® Implant n=26 Participants 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
Change in New York Heart Association (NYHA) Classification Improved	19 participants	15 participants
Change in New York Heart Association (NYHA) Classification No Change	13 participants	6 participants
Change in New York Heart Association (NYHA) Classification Worsened	4 participants	5 participants

SECONDARY outcome

Timeframe: Preimplant through 6 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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=30 Participants 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	Tri-Ad® Implant n=21 Participants 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
Change in New York Heart Association (NYHA) Classification Improved	20 participants	19 participants
Change in New York Heart Association (NYHA) Classification No Change	8 participants	1 participants
Change in New York Heart Association (NYHA) Classification Worsened	2 participants	1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contour 3D® Implant n=26 Participants 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	Tri-Ad® Implant n=21 Participants 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
Change in New York Heart Association (NYHA) Classification . Improved	19 participants	17 participants
Change in New York Heart Association (NYHA) Classification . No Change	7 participants	3 participants
Change in New York Heart Association (NYHA) Classification . Worsened	0 participants	1 participants

Adverse Events

Contour 3D® Implant

Serious events: 16 serious events

Other events: 2 other events

Deaths: 0 deaths

Tri-Ad® Implant

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Contour 3D® Implant n=36 participants at risk 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	Tri-Ad® Implant n=28 participants at risk 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
Cardiac disorders Atrioventricular block first degree	5.6% 2/36 • Number of events 2 • 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.	0.00% 0/28 • 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.
Cardiac disorders Atrial fibrillation	5.6% 2/36 • Number of events 2 • 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.	0.00% 0/28 • 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.

Additional Information

Shari Benoit

Medtronic Coronary and Structural Heart

Phone: (763) 514-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Contour 3D® Implant n=36 participants at risk 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	Tri-Ad® Implant n=28 participants at risk 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
Blood and lymphatic system disorders Coagulopathy	0.00% 0/36 • 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.	3.6% 1/28 • Number of events 1 • 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.
Blood and lymphatic system disorders Thrombocytopenia	2.8% 1/36 • Number of events 1 • 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.	0.00% 0/28 • 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.
Cardiac disorders Atrial fibrillation	5.6% 2/36 • Number of events 3 • 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.	10.7% 3/28 • Number of events 3 • 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.
Cardiac disorders Atrioventricular block complete	5.6% 2/36 • Number of events 2 • 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.	0.00% 0/28 • 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.
Cardiac disorders Atrioventricular block second degree	5.6% 2/36 • Number of events 2 • 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.	0.00% 0/28 • 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.
Cardiac disorders Bradycardia	2.8% 1/36 • Number of events 1 • 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.	0.00% 0/28 • 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.
Cardiac disorders Cardiac failure congestive	2.8% 1/36 • Number of events 1 • 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.	3.6% 1/28 • Number of events 1 • 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.
Cardiac disorders Coronary artery embolism	2.8% 1/36 • Number of events 1 • 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.	0.00% 0/28 • 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.
Cardiac disorders Nodal rhythm	2.8% 1/36 • Number of events 1 • 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.	7.1% 2/28 • Number of events 2 • 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.
Cardiac disorders Sinus node dysfunction	5.6% 2/36 • Number of events 2 • 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.	3.6% 1/28 • Number of events 1 • 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.
Gastrointestinal disorders Ileus	2.8% 1/36 • Number of events 1 • 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.	0.00% 0/28 • 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.
Injury, poisoning and procedural complications Postoperative respiratory failure	2.8% 1/36 • Number of events 1 • 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.	0.00% 0/28 • 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.
Investigations Cardiac output decreased	2.8% 1/36 • Number of events 1 • 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.	0.00% 0/28 • 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.
Nervous system disorders Cerebrovascular accident	2.8% 1/36 • Number of events 1 • 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.	3.6% 1/28 • Number of events 2 • 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.
Renal and urinary disorders Renal failure	2.8% 1/36 • Number of events 1 • 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.	3.6% 1/28 • Number of events 1 • 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.
Renal and urinary disorders Renal failure acute	8.3% 3/36 • Number of events 3 • 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.	0.00% 0/28 • 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.8% 1/36 • Number of events 1 • 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.	0.00% 0/28 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.8% 1/36 • Number of events 1 • 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.	7.1% 2/28 • Number of events 2 • 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.
Vascular disorders Hypotension	2.8% 1/36 • Number of events 1 • 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.	3.6% 1/28 • Number of events 1 • 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.