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Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Primary Purpose

Tricuspid Regurgitation

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Minimally Invasive Tricuspid Surgery

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgery group

Medical group

Arm Description

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

receiving medical treatment only

Outcomes

Primary Outcome Measures

the rate of all-cause death, re-hospitalization due to right heart failure or both of them

Secondary Outcome Measures

right heart function

echocardiography-based measurement of right heart function

New York Heart Association functional class

New York Heart Association functional class including I, II, III, IV class

liver function

total bilirubin, conjugated bilirubin

liver function

prealbumin.

kidney function

blood urea nitrogen

kidney function

creatinine

kidney function

uric acid.

life quality scores

quality of life using the SF-12 form

Full Information

NCT ID

NCT04339192

First Posted

April 5, 2020

Last Updated

April 8, 2020

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04339192

Brief Title

Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2020 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tricuspid Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery group

Arm Type

Experimental

Arm Description

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

Arm Title

Medical group

Arm Type

No Intervention

Arm Description

receiving medical treatment only

Intervention Type

Procedure

Intervention Name(s)

Minimally Invasive Tricuspid Surgery

Intervention Description

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.

Primary Outcome Measure Information:

Title

the rate of all-cause death, re-hospitalization due to right heart failure or both of them

Description

the rate of all-cause death, re-hospitalization due to right heart failure or both of them

Time Frame

2 years

Secondary Outcome Measure Information:

Title

right heart function

Description

echocardiography-based measurement of right heart function

Time Frame

2 years

Title

New York Heart Association functional class

Description

New York Heart Association functional class including I, II, III, IV class

Time Frame

2 years

Title

liver function

Description

total bilirubin, conjugated bilirubin

Time Frame

2 years

Title

liver function

Description

prealbumin.

Time Frame

2 years

Title

kidney function

Description

blood urea nitrogen

Time Frame

2 years

Title

kidney function

Description

creatinine

Time Frame

2 years

Title

kidney function

Description

uric acid.

Time Frame

2 years

Title

life quality scores

Description

quality of life using the SF-12 form

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jinmiao Chen, MD, PhD

Phone

+86 15121036927

chen.jinmiao@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunsheng Wang, MD

Organizational Affiliation

Zhongshan Hospital, Fudan Univerisity

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinmiao Chen, MD, PhD

Phone

+86 15121036927

chen.jinmiao@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Chunsheng Wang, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Now we have decided not to make IPD available to other researchers.

Citations:

PubMed Identifier

31157373

Citation

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.

Results Reference

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Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

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