EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-01-31

Brief Summary

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Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment.

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Detailed Description

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The EASE TRICUSPID Clinical Trial was a prospective, non-randomized, non-interventional, post-market release study. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment. Therefore, the primary objective of the EASE Tricuspid Study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring (Contour 3D ring) in subjects with tricuspid regurgitation who had a clinical indication for TV repair in a post-market use. Secondary objectives included the evaluation of the effect of TV repair with the Contour 3D ring on the right ventricular function, as well as the assessment of the effect of TV repair with the Contour 3D ring on the functional status in subjects undergoing TV repair in a post-market environment. Subjects eligible for TV repair and compliant with the enrollment criteria were considered by the Investigator for inclusion in the study. To minimize bias, enrolled subjects were followed by their own physician in accordance with the center's established practice for routine follow up. Follow-up sessions were planned at the physician's discretion. To meet the intended goals, appropriate clinical data were collected at baseline (pre-surgery), during the surgical procedure, at discharge and during the follow-up period at 6 months. Experienced echo-cardiologists evaluated the echos. At the time of enrollment it was not certain if the subject would receive a Contour 3D ring, since the surgeon might have decided during surgery that another treatment was more beneficial to the subject. In this case, the subject was terminated from the study.

Conditions

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Tricuspid Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with Tricuspid Valve Repair

All patients indicated for a Tricuspid Valve (TV) repair procedure concomitantly to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.

Tricuspid valve repair

Intervention Type PROCEDURE

Left-sided heart surgery

Intervention Type PROCEDURE

Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned

Contour 3D Tricuspid Annuloplasty Ring

Intervention Type DEVICE

Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair

Interventions

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Tricuspid valve repair

Intervention Type PROCEDURE

Left-sided heart surgery

Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned

Intervention Type PROCEDURE

Contour 3D Tricuspid Annuloplasty Ring

Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Willing to sign and date the Patient Informed Consent (PIC)
* Indicated for a concomitant surgical repair of the TV
* Willing to return to the hospital, where the implantation originally occurred, for a 6 month follow-up visit

Exclusion Criteria

* Patients with a degenerative TV condition
* Patients with primary TV regurgitation
* Previous TV repair or replacement
* Stand-alone TV repair
* Already participating in another investigational device or drug study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
* Life expectancy of less than one year
* Pregnant or desire to be pregnant within 12 months of the study treatment
* Under 18 years or over 85 years of age
* Patients with active endocarditis
* Patients with valvular retraction with severely reduced mobility
* Patients with a heavily calcified TV

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No