Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

NCT ID: NCT04339192

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2024-06-01

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.

Conditions

Tricuspid Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery group

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

Group Type: EXPERIMENTAL

Minimally Invasive Tricuspid Surgery

Intervention Type: 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.

Medical group

receiving medical treatment only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunsheng Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital, Fudan Univerisity

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinmiao Chen, MD, PhD

Role: CONTACT

chen.jinmiao@zs-hospital.sh.cn

+86 15121036927

Facility Contacts

Jinmiao Chen, MD, PhD

Role: primary

chen.jinmiao@zs-hospital.sh.cn

+86 15121036927

References

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.

Reference Type: BACKGROUND

PMID: 31157373 (View on PubMed)

Other Identifiers

B2020-036R

Identifier Type: -

Identifier Source: org_study_id