Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Last updated: April 8, 2020
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT04339192
B2020-036R
  • Ages 18-80
  • All Genders

Study Summary

Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage. Over the past 3 decades, with the advances in minimally invasive surgical techniques, operative mortality after reoperation for severe TR has significantly decreased from 30% to 3-8%, leading to a gradual shift from medical therapy alone to surgery in those patients. However, there has been no consensus on the clinical benefit of minimally invasive tricuspid surgery over medical therapy for severe TR after LSVS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Severe tricuspid regurgitation, as assessed by the clinical site echocardiographerusing the transthoracic echocardiography.

  2. A history of LSVS, including one or multiple procedures of aortic and/or mitral valverepair and/or replacement.

  3. Left ventricular ejection fraction (LVEF) >45%, systolic pulmonary artery pressure <60mmHg with pulmonary vascular resistance <6 woods unit.

  4. Age ≥ 18 years.

  5. Able to sign Informed Consent forms.

Exclusion

Exclusion Criteria:

  1. TR due to: infective endocarditis, congenital tricuspid valve malformation, secondaryto correction of congenital heart disease.

  2. Left-sided valve dysfunction or coronary artery disease requiring concomitantprocedures.

  3. Prior surgical or percutaneous tricuspid valve intervention.

  4. Evidence of an acute myocardial infarction in the prior 90 days

  5. Contraindications to cardiopulmonary bypass or the expected operative mortality >30% (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II).

  6. Any comorbidity with life expectancy <2 years

  7. Recent history of psychiatric disease (including drug or alcohol abuse) that is likelyto impair compliance with the study protocol.

  8. Pregnancy at the time of randomization.

Study Design

Total Participants: 330
Study Start date:
May 01, 2020
Estimated Completion Date:
June 01, 2024

Study Description

In this multi-center randomized controlled trial, patients with severe TR after LSVS will be recruited. The patients will be randomly assigned to surgery plus medical therapy (surgery group) or medical therapy alone (control group). The primary outcome will be a composite of all-cause mortality, re-admission for right heart failure or the composite. Furthermore, echocardiography-based measurement of right heart function, New York Heart Association functional class, liver and kidney function, and quality of life will be compared between the 2 groups. All outcomes will be assessed at baseline and 6, 12 and 24 months after randomization.

Connect with a study center

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.