Effectiveness and Durability Long-term Results of Tricusp... | NCT05836415

Studies
Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.

NCT05836415

Sponsor

Michele De Bonis

Status

Completed

Last Update Posted

May 1, 2023Actual

Enrollment

168Actual

Phase

Not provided

Conditions

Functional Tricuspid Regurgitation

Interventions

Tricuspid valve annuloplasty with 3D ring

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2020Actual

Primary Completion Date

Dec 29, 2020Actual

Completion Date

Dec 29, 2020Actual

First Submitted Date

Jan 27, 2023

First Submission Date that Met QC Criteria

Apr 28, 2023

First Posted Date

May 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2023

Last Update Posted Date

May 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michele De Bonis, Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San RaffaeleSponsor-Investigator

Lead Sponsor

Michele De BonisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Interest in tricuspid valve disease has grown exponentially over the past few years, in response to increased interest in the poor prognosis of patients with functional tricuspid regurgitation (TR). Tricuspid valve repair (TVR) using a prosthetic ring represents the first option in many centers worldwide, due to the low incidence of residual and recurrent TR and improved survival compared to suture techniques. The goal of ring annuloplasty is to restore the normal geometry of the annulus, thereby improving the coaptation of the leaflets and preventing further dilatation of the annulus. Recently, the three-dimensional geometry of the tricuspid valve has been shown and analyzed by means of data obtained from echocardiography, CT scan and magnetic resonance imaging. Normal tricuspid annulus is characterized by a more prominent part in the anteroseptal commissure area near the aortic valve and right ventricular outflow tract and a deeper part in the posteroseptal commissure area near the coronary sinus ostium . Based on these characteristics, new three-dimensional rings have been developed for tricuspid annuloplasty, such as the MC3 (Edwards Lifescience, Irvine, CA) and the Contour 3D (Medtronic, Minneapolis, MN).

There are few studies concerning the short-term results of tricuspid rings implantation and almost none on the long-term, therefore this study aims to analyze the long-term results of TVR by implantation of the two new prosthetic ring models mentioned above.

The aim of this study is the long-term analysis of the results of tricuspid annuloplasty with three-dimensional rings in patients with functional IT.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

168Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tricuspid valve annuloplasty with 3D ring	Procedure	A 3D ring is implanted to treat functional tricuspid valve regurgitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		through study completion, an average of 7 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients
Operated for functional TR
Implantation of three-dimensional tricuspid prosthetic ring MC3 or Contour 3D, isolated or concomitant to surgery on the left heart sections
Surgical access in median sternotomy or minithoracotomy

Exclusion Criteria:

- emergency/urgency intervention

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent tricuspid surgery due to functional tricuspid regurgitation, treated with implant of a 3D ring

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Ospedale San Raffaele		Milan		20132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided