Clinical trial NCT01532921: EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
Official title: EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Valve Insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 85
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 patient population includes all patients indicated for a 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. Patients with primary TV are not included, since this is often characterized by pathological leaflets for which the Contour 3D® Tricuspid Annuloplasty Ring would not be beneficial.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Gradient Across the Tricuspid Valve
timeFrame: At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant
measure: Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
timeFrame: Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant
measure: Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant
timeFrame: Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant
measure: Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant
timeFrame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Secondary outcomes:
measure: Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant
timeFrame: Basline to Discharge (up to 5 days post-implant) and 6 months post-implant
measure: Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant
timeFrame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
measure: Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant
timeFrame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
measure: Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
timeFrame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de Lyon - Hôpital Louis Pradel
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Hamburg
country: Germany
facility: Albertinen Herz- und Gefäßzentrum
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Be'er Sheeva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Deutsches Herzzentrum München
name: Rüdiger Lange, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guenzinger R, Lange RS, Riess FC, Hanke T, Bischoff N, Obadia JF, Sahar G, Bitran D, Roberts H Jr, Li S, Bolling SF. Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation. Thorac Cardiovasc Surg. 2020 Sep;68(6):478-485. doi: 10.1055/s-0038-1673665. Epub 2018 Nov 16.