NCT03604484

Brief Summary

Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

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

May 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2010

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

July 11, 2018

Last Update Submit

July 19, 2018

Conditions

Tricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Incidence of more than mild tricuspid insufficiency

    5 year

Secondary Outcomes (2)

  • VO2 max

    1 year

  • Right ventricular function

    5 year

Study Arms (2)

Tricuspid annuloplasty

ACTIVE COMPARATOR

Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery

Procedure: Tricuspid annuloplasty

No Tricuspid annuloplasty

NO INTERVENTION

Control patients

Interventions

Tricuspid annuloplastyPROCEDURE

Tricuspid annuloplasty

Tricuspid annuloplasty

Eligibility Criteria

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

You may qualify if:

  • patients undergoing mitral valve surgery with less than sever tricuspid insufficiency

You may not qualify if:

  • presence of pacemaker lead through the tricuspid valve
  • acute endocarditis
  • minimally invasive approach
  • Functional mitral valve insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 27, 2018

Study Start

May 1, 2009

Primary Completion

December 31, 2010

Study Completion

January 1, 2017

Last Updated

July 27, 2018

Record last verified: 2018-07