Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Trial Purpose and Description

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not.



At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

Ages: 18 years and older

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Undergoing MVS for degenerative MR with (a) Moderate TR as determined by transthoracic 2D echocardiography, or (b) Tricuspid annular dimension ≥ 40 mm (index: ≥21mm/M2 BSA) and trace/mild TR, determined by echocardiography.
  • Age ≥ 18 years
  • Able to sign Informed Consent and Release of Medical Information forms

Exclusion Criteria:

  • Functional MR
  • Evidence of sub-optimal fluid management (e.g., lack of diuretics, weight in excess of dry weight) in the opinion of the cardiology investigator
  • Structural / organic TV disease
  • Severe TV regurgitation as determined by preoperative transthoracic echocardiography (TTE)
  • Implanted pacemaker or defibrillator, where the leads cross the TV from the right atrium into the right ventricle
  • Concomitant cardiac surgery other than atrial fibrillation correction surgery (PVI, Maze, LAA closure), closure of PFO or ASD, or CABG
  • Cardiogenic shock at the time of randomization
  • STEMI 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
  • Therapy with an investigational intervention at the time of screening, or plan to enroll patient in additional investigational intervention study during participation in this trial
  • Any concurrent disease with life expectancy < 2 years
  • Unable or unwilling to provide informed consent
  • Unable or unwilling to comply with study follow up in the opinion of the investigator

German Society for Thoracic and Cardiovascular Surgery

Dates: 06/29/2017 - 05/31/2018

Last Updated: 06/30/2017

Study HIC#: 2000020514

Get Involved

For more information about this study, contact:
Marianne M. McCarthy
203-737-8319
marianne.mccarthy@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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