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Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

NCT04339192 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2020-04-09

No results posted yet for this 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.

Conditions

  • Tricuspid Regurgitation

Interventions

PROCEDURE

Minimally Invasive Tricuspid Surgery

minimally invasive tricuspid surgery including endoscopy-assist right minithoracotomy, vacuum-assist single femoral venous drainage without dissecting or snaring vena cava, direct right atriotomy through pericardium and the beating-heart technique.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Chunsheng Wang, MD · Zhongshan Hospital, Fudan Univerisity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2023-12-31
Completion
2024-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04339192 on ClinicalTrials.gov