Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

NCT04339192 | Unknown

• 1 other identifier: B2020-036R
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• right heart function

  2 years

• New York Heart Association functional class

  2 years

• liver function

  2 years

• liver function

  2 years

• kidney function

  2 years

Study Arms (2)

Surgery group

EXPERIMENTAL

receiving minimally invasive tricuspid surgery including tricuspid valve replacement or repair plus medical treatment.

Procedure: Minimally Invasive Tricuspid Surgery

Medical group

NO INTERVENTION

receiving medical treatment only

Interventions

Minimally Invasive Tricuspid Surgery PROCEDURE

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.

Surgery group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary to correction of congenital heart disease.
• Left-sided valve dysfunction or coronary artery disease requiring concomitant procedures.
• Prior surgical or percutaneous tricuspid valve intervention.
• Evidence of an acute myocardial infarction in the prior 90 days
• Contraindications to cardiopulmonary bypass or the expected operative mortality \>30% (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II).
• Any comorbidity with life expectancy \<2 years
• Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol.
• Pregnancy at the time of randomization.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31157373 BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Chunsheng Wang, MD

  Zhongshan Hospital, Fudan Univerisity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinmiao Chen, MD, PhD

CONTACT

+86 15121036927; chen.jinmiao@zs-hospital.sh.cn

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: April 5, 2020
• First Posted: April 9, 2020
• Study Start: May 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)