Clinical trial NCT01585779: Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
Official title: Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Valve Regurgitation
Tricuspid Valve Insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® or Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® or Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Degree of Tricuspid Regurgitation
timeFrame: Preimplant through Discharge
measure: Change in the Degree of Tricuspid Regurgitation
timeFrame: Preimplant through 6 Months
measure: Change in the Degree of Tricuspid Regurgitation
timeFrame: Preimplant through 12 Months
measure: The Mean Gradient Across the Tricuspid Valve
timeFrame: Discharge
measure: The Mean Gradient Across the Tricuspid Valve
timeFrame: 6 months
measure: The Mean Gradient Across the Tricuspid Valve
timeFrame: 12 months
measure: Change in the Degree of TV Leaflet Coaptation Length
timeFrame: Preimplant through Discharge
measure: Change in the Degree of TV Leaflet Coaptation Length
timeFrame: Preimplant through 6 Months
measure: Change in the Degree of TV Leaflet Coaptation Length
timeFrame: Preimplant through 12 Months
measure: Change in the Degree of TV Leaflet Tethering Height
timeFrame: Preimplant through Discharge
measure: Change in the Degree of TV Leaflet Tethering Height
timeFrame: Preimplant through 6 Months
measure: Change in the Degree of TV Leaflet Tethering Height
timeFrame: Preimplant through 12 Months
Secondary outcomes:
measure: Change in the Right Ventricle (RV) Diastolic Area
timeFrame: Preimplant through Discharge
measure: Change in the Right Ventricle (RV) Diastolic Area
timeFrame: Preimplant through 6 Months
measure: Change in the Right Ventricle (RV) Diastolic Area
timeFrame: Preimplant through 12 Months
measure: Change in the Tricuspid Annular (Basal) Diameter
timeFrame: Preimplant through Discharge
measure: Change in the Tricuspid Annular (Basal) Diameter
timeFrame: Preimplant through 6 Months
measure: Change in the Tricuspid Annular (Basal) Diameter
timeFrame: Preimplant through 12 Months
measure: Change in the RV Fractional Area
timeFrame: Preimplant through Discharge
measure: Change in the RV Fractional Area
timeFrame: Preimplant through 6 Months
measure: Change in the RV Fractional Area
timeFrame: Preimplant through 12 Months
measure: Demographic Data
timeFrame: Baseline
measure: Change in New York Heart Association (NYHA) Classification
timeFrame: Preimplant through Discharge
measure: Change in New York Heart Association (NYHA) Classification
timeFrame: Preimplant through 6 months
measure: Change in New York Heart Association (NYHA) Classification .
timeFrame: Preimplant through 12 months
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Florida Heart & Vascular Care at Aventura
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Asheville
country: United States
facility: Mission Hospital Research Institute
state: North Carolina
Study officials:
affiliation: Medtronic
name: Eric Vang
role: STUDY_DIRECTOR
References: