NCT03278418

Brief Summary

Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

4 years

First QC Date

August 31, 2017

Last Update Submit

September 7, 2017

Conditions

Tricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Significant TR (moderate or severe)

    To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (\>10 cm2).

    3 years

Secondary Outcomes (6)

  • Significant TR (moderate or severe)

    1 and 2 years

  • Mild TR

    1,2 and 3 years

  • Overall TR (mild, moderate, severe)

    1, 2 and 3 years

  • RV function

    1, 2 and 3 years

  • Pulmonary Artery Pressure (PAP)

    1, 2 and 3 years

  • +1 more secondary outcomes

Study Arms (2)

Tricuspid Valve Repair

EXPERIMENTAL

Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery

Procedure: Tricuspid Valve RepairProcedure: Left-sided valve surgery

left-sided valve surgery

ACTIVE COMPARATOR

No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery

Procedure: Left-sided valve surgery

Interventions

Tricuspid Valve RepairPROCEDURE

It will be performed according to the surgeon preference

Tricuspid Valve Repair
Left-sided valve surgeryPROCEDURE

It will be performed according to the surgeon preference

Tricuspid Valve Repairleft-sided valve surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing left-sided valve surgery for left-sided valve disease
  • Presence of non-severe TR and tricuspid annular dilation (\>40 mm or \> 21 mm/m2 BSA) determined by echocardiography
  • Age ≥ 18 years
  • Capability to sign Informed Consent and Release of Medical Information forms

You may not qualify if:

  • Preoperative severe TR
  • Structural / organic tricuspid valve disease
  • Tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 BSA) on preoperative TTE
  • Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the RV
  • Any type of reoperative surgery
  • Concomitant cardiac surgery other than atrial fibrillation correction surgery (pulmonary vein isolation, Maze procedure, left atrial appendage closure) or closure of patent foramen ovale or atrial septal defect (for example, concomitant coronary artery bypass graft or aortic surgery)
  • Cardiogenic shock at the time of randomization
  • ST-elevated myocardial infarction requiring intervention within 7 days prior to randomization
  • Evidence of cirrhosis or hepatic synthetic failure
  • Severe, irreversible pulmonary hypertension in the judgment of the investigator
  • Pregnancy at the time of randomization
  • Any concurrent disease with life expectancy \< 1 year
  • Patient unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

Location

IRCCS Policlinico San Donato

Milan, 20097, Italy

Location

IRCCS Opsedale San Raffaele

Milan, 20132, Italy

Location

Maria Eleonora Hospital

Palermo, 90135, Italy

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Maria Salomone, MD

    Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS

    STUDY DIRECTOR

Central Study Contacts

Mauro Del Giglio, MD

CONTACT

+390545217445mdelgiglio@gvmnet.it

Donato Mele, MD

CONTACT

+393476411190donatomele@libero.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 11, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(4)