This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial (Contour3D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01585779
First received: April 18, 2012
Last updated: May 4, 2017
Last verified: May 2017
Results First Received: March 21, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Tricuspid Valve Regurgitation
Tricuspid Valve Insufficiency
Interventions: Device: Contour 3D® implant for tricuspid valve repair
Device: Tri-Ad® implant for tricuspid valve repair

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Contour 3D® Implant   Tri-Ad® Implant
STARTED   36   28 
COMPLETED   26   21 
NOT COMPLETED   10   7 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Contour 3D® Implant   Tri-Ad® Implant   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   28   64 
Age 
[Units: Participants]
Count of Participants
     
<=18 years   0   0   0 
Between 18 and 65 years   13   3   16 
>=65 years   23   25   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.4  (11.6)   73.7  (8.5)   70.7  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   15   18   33 
Male   21   10   31 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Degree of Tricuspid Regurgitation   [ Time Frame: Preimplant through Discharge ]

2.  Primary:   Change in the Degree of Tricuspid Regurgitation   [ Time Frame: Preimplant through 6 Months ]

3.  Primary:   Change in the Degree of Tricuspid Regurgitation   [ Time Frame: Preimplant through 12 Months ]

4.  Primary:   The Mean Gradient Across the Tricuspid Valve   [ Time Frame: Discharge ]

5.  Primary:   The Mean Gradient Across the Tricuspid Valve   [ Time Frame: 6 months ]

6.  Primary:   The Mean Gradient Across the Tricuspid Valve   [ Time Frame: 12 months ]

7.  Primary:   Change in the Degree of TV Leaflet Coaptation Length   [ Time Frame: Preimplant through Discharge ]

8.  Primary:   Change in the Degree of TV Leaflet Coaptation Length   [ Time Frame: Preimplant through 6 Months ]

9.  Primary:   Change in the Degree of TV Leaflet Coaptation Length   [ Time Frame: Preimplant through 12 Months ]

10.  Primary:   Change in the Degree of TV Leaflet Tethering Height   [ Time Frame: Preimplant through Discharge ]

11.  Primary:   Change in the Degree of TV Leaflet Tethering Height   [ Time Frame: Preimplant through 6 Months ]

12.  Primary:   Change in the Degree of TV Leaflet Tethering Height   [ Time Frame: Preimplant through 12 Months ]

13.  Secondary:   Change in the Right Ventricle (RV) Diastolic Area   [ Time Frame: Preimplant through Discharge ]

14.  Secondary:   Change in the Right Ventricle (RV) Diastolic Area   [ Time Frame: Preimplant through 6 Months ]

15.  Secondary:   Change in the Right Ventricle (RV) Diastolic Area   [ Time Frame: Preimplant through 12 Months ]

16.  Secondary:   Change in the Tricuspid Annular (Basal) Diameter   [ Time Frame: Preimplant through Discharge ]

17.  Secondary:   Change in the Tricuspid Annular (Basal) Diameter   [ Time Frame: Preimplant through 6 Months ]

18.  Secondary:   Change in the Tricuspid Annular (Basal) Diameter   [ Time Frame: Preimplant through 12 Months ]

19.  Secondary:   Change in the RV Fractional Area   [ Time Frame: Preimplant through Discharge ]

20.  Secondary:   Change in the RV Fractional Area   [ Time Frame: Preimplant through 6 Months ]

21.  Secondary:   Change in the RV Fractional Area   [ Time Frame: Preimplant through 12 Months ]

22.  Secondary:   Demographic Data   [ Time Frame: Baseline ]

23.  Secondary:   Change in New York Heart Association (NYHA) Classification   [ Time Frame: Preimplant through Discharge ]

24.  Secondary:   Change in New York Heart Association (NYHA) Classification   [ Time Frame: Preimplant through 6 months ]

25.  Secondary:   Change in New York Heart Association (NYHA) Classification .   [ Time Frame: Preimplant through 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Shari Benoit
Organization: Medtronic Coronary and Structural Heart
phone: (763) 514-4000 ext 9749
e-mail: shari.g.benoit@medtronic.com



Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01585779     History of Changes
Other Study ID Numbers: 10030481DOC
Study First Received: April 18, 2012
Results First Received: March 21, 2017
Last Updated: May 4, 2017