NCT03144024

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2019

Completed
Last Updated

July 21, 2020

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

May 4, 2017

Last Update Submit

July 19, 2020

Conditions

Tricuspid Regurgitation

Keywords

Tricuspid RegurgitationInsufficiency, Tricuspid ValveValvular AnnuloplastyCardiac Valve Annulus Repair

Outcome Measures

Primary Outcomes (2)

  • tricuspid regurgitation

    12 months

  • death

    12 months

Secondary Outcomes (1)

  • right ventricle function

    12 months

Study Arms (2)

band

EXPERIMENTAL
Device: band implantation

Rigid ring

ACTIVE COMPARATOR
Device: rigid ring implantation

Interventions

band implantationDEVICE
band
rigid ring implantationDEVICE
Rigid ring

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate or severe tricuspid regurgitation

You may not qualify if:

  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MeshalkinRI

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

September 14, 2016

Primary Completion

September 14, 2017

Study Completion

September 14, 2019

Last Updated

July 21, 2020

Record last verified: 2016-09

Locations

RU(1)