Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Minimally Invasive Tricuspid Surgery Versus Medical Treatment for Severe Tricuspid Regurgitation After Left-sided Valve Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Procedure: Minimally Invasive Tricuspid Surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinmiao Chen, MD, PhD; Phone Number: +86 15121036927; Email: chen.jinmiao@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Jinmiao Chen, MD, PhD; Phone Number: +86 15121036927; Email: chen.jinmiao@zs-hospital.sh.cn
      • Principal Investigator: Chunsheng Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Severe tricuspid regurgitation, as assessed by the clinical site echocardiographer using the transthoracic echocardiography.
2. A history of LSVS, including one or multiple procedures of aortic and/or mitral valve repair and/or replacement.
3. Left ventricular ejection fraction (LVEF) >45%, systolic pulmonary artery pressure <60 mmHg with pulmonary vascular resistance <6 woods unit.
4. Age ≥ 18 years.
5. Able to sign Informed Consent forms.

Exclusion Criteria:

1. TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary to correction of congenital heart disease.
2. Left-sided valve dysfunction or coronary artery disease requiring concomitant procedures.
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 likely to impair compliance with the study protocol.
8. Pregnancy at the time of randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery group; receiving minimally invasive tricuspid surgery including tricuspid valve replacement or repair plus medical treatment.	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.
No Intervention: Medical group; receiving medical treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of all-cause death, re-hospitalization due to right heart failure or both of them	the rate of all-cause death, re-hospitalization due to right heart failure or both of them	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
right heart function	echocardiography-based measurement of right heart function	2 years
New York Heart Association functional class	New York Heart Association functional class including I, II, III, IV class	2 years
liver function	total bilirubin, conjugated bilirubin	2 years
liver function	prealbumin.	2 years
kidney function	blood urea nitrogen	2 years
kidney function	creatinine	2 years
kidney function	uric acid.	2 years
life quality scores	quality of life using the SF-12 form	2 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Chunsheng Wang, MD, Zhongshan Hospital, Fudan Univerisity

Publications and helpful links

General Publications

• Chen J, Hu K, Ma W, Lv M, Shi Y, Liu J, Wei L, Lin Y, Hong T, Wang C. Isolated reoperation for tricuspid regurgitation after left-sided valve surgery: technique evolution. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):142-150. doi: 10.1093/ejcts/ezz160.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 5, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: B2020-036R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Now we have decided not to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No