Tricuspid RegurgitationNCT04339192
Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR
A study testing Minimally Invasive Tricuspid Surgery in people with Tricuspid Regurgitation, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Minimally Invasive Tricuspid Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jinmiao Chen, MD, PhD, +86 15121036927, chen.jinmiao@zs-hospital.sh.cn
Chunsheng Wang, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Minimally Invasive Tricuspid Surgery
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Tricuspid SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | Experimental | receiving minimally invasive tricuspid surgery including tricuspid valve replacement or repair plus medical treatment. Receives: Procedure: Minimally Invasive Tricuspid Surgery |
| Medical group | No intervention | receiving medical treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (8)
right heart function
echocardiography-based measurement of right heart function
Measured: 2 years
New York Heart Association functional class
New York Heart Association functional class including I, II, III, IV class
Measured: 2 years
liver function
total bilirubin, conjugated bilirubin
Measured: 2 years
liver function
prealbumin.
Measured: 2 years
kidney function
blood urea nitrogen
Measured: 2 years
kidney function
creatinine
Measured: 2 years
kidney function
uric acid.
Measured: 2 years
life quality scores
quality of life using the SF-12 form
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunsheng Wang, MD, Principal investigator, Zhongshan Hospital, Fudan Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339192
- Sponsor's protocol ID
- B2020-036R
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Now we have decided not to make IPD available to other researchers.
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.
PubMed 31157373
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Tricuspid Surgery Versus Medical Treatment for Severe Tricuspid Regurgitation After Left-sided Valve Surgery
- ClinicalTrials.gov ID
- NCT04339192
- Acronym / sponsor ID
- B2020-036R
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group | Experimental | Procedure: Minimally Invasive Tricuspid Surgeryreceiving minimally invasive tricuspid surgery including tricuspid valve replacement or repair plus medical treatment. |
| Medical group | No intervention | –receiving medical treatment only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Tricuspid Surgeryminimally 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. | Procedure or surgery | Surgery group |
Primary outcome
the rate of all-cause death, re-hospitalization due to right heart failure or both of them
Time frame: 2 years
the rate of all-cause death, re-hospitalization due to right heart failure or both of them
8 secondary outcomes
right heart function
Time frame: 2 years
New York Heart Association functional class
Time frame: 2 years
liver function
Time frame: 2 years
liver function
Time frame: 2 years
kidney function
Time frame: 2 years
kidney function
Time frame: 2 years
kidney function
Time frame: 2 years
life quality scores
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Background: PubMed 31157373Chen 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.
- Individual participant dataSharing planned: No. Now we have decided not to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunsheng Wang, MD principal investigator
Zhongshan Hospital, Fudan Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Tricuspid Surgery in people with Tricuspid Regurgitation, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinmiao Chen, MD, PhD (+86 15121036927, chen.jinmiao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of all-cause death, re-hospitalization due to right heart failure or both of them (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.