Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Tricuspid Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04339192
• Other study ID #: B2020-036R
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Jinmiao Chen, MD, PhD
• Phone: +86 15121036927
• Email: chen.jinmiao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

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