Comparison of Rigid Annuloplasty Ring With a Band in the... | NCT03144024

Studies
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency

NCT03144024

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Status

Completed

Last Update Posted

Jul 21, 2020Actual

Enrollment

308Actual

Phase

Not Applicable

Conditions

Tricuspid Regurgitation

Interventions

band implantation
rigid ring implantation

Countries

Russia

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

Sep 2016

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

Sep 14, 2016Actual

Primary Completion Date

Sep 14, 2017Actual

Completion Date

Sep 14, 2019Actual

First Submitted Date

May 4, 2017

First Submission Date that Met QC Criteria

May 5, 2017

First Posted Date

May 8, 2017Actual

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

Jul 19, 2020

Last Update Posted Date

Jul 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.

Detailed Description

study include 308 patients. Patient will be randomized and 154 patient will receive band for treatment tricuspid regurgitation, rest patient will receive rigid ring. Follow up will be 1 year. Primary outcome - freedom of moderate or severe regurgitation. Secondary outcome - RV function, quality of life.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

308Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
band	Experimental		Device: band implantation
Rigid ring	Active Comparator		Device: rigid ring implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
band implantation	Device		band
rigid ring implantation

Measure	Description	Time Frame
tricuspid regurgitation		12 months
death		12 months

Measure	Description	Time Frame
right ventricle function		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

moderate or severe tricuspid regurgitation

Exclusion Criteria:

refusal to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MeshalkinRI		Novosibirsk		630055	Russia

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided