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Residual Tricuspid RegurgitationNCT04414358

Incidence of Residual Tricuspid Regurgitation in Patients Undergoing Left-heart Surgery

An observational study of Residual Tricuspid Regurgitation and Left-sided Cardiac Surgery, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at the same setting. Residual tricuspid regurgitation may effects patients' outcome. Read more about this study

Who is it for?
Ages 18 years and older
How many people
275 participants
Where
1 siteThailand
Study dates
20 Nov 2020to 30 Apr 2022
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The patients scheduled for surgery according to the criteria in Siriraj hospital, Mahidol university will be recruited

Who may be able to join

  • Mitral valve or aortic valve diseases requiring surgical intervention
  • No pathologic changes in TV leaflets
  • No previous tricuspid valve surgery

Who cannot join

  • Patients with incomplete data
  • Patient with history of previous cardiac surgery
  • Patient with congenital anomalies of mitral or tricuspid valve
  • Patient with both tricuspid stenosis and regurgitation

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Faculty of Medicine Siriraj Hospital

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: Incidence of Residual Significant Tricuspid Regurgitation in Patients Undergoing Left-sided Cardiac Surgery

Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at the same setting. Residual tricuspid regurgitation may effects patients' outcome. The investigators would like to determine the incidence of significant residual tricuspid regurgitation after left-sided cardiac surgery and related clinical outcome.

Read the detailed description

Functional tricuspid regurgitation (TR) was defined as TR occurring secondary to left heart, especially mitral valve stenosis or pulmonary disease. Previous study reported that about 30% - 50% of patients with significant mitral stenosis developed moderate to severe TR. In the past, corrective TR repair was not always indicated because the concept about TR severity will improve after mitral valve lesion was treated.

Later on, several studies demonstrated that the patients with untreated significant (< moderate) TR had worse clinical outcome including mortality. While simultaneous functional TR repair with left-sided valve surgery did not cause adverse events, but improve clinical outcome and quality of life. The current European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) and American Heart Association(AHA)/American College of Cardiology (ACC) guidelines recommend concomitant tricuspid valve (TV) surgery in patients with severe TR undergoing left-sided valve surgery (class I recommendation). In patients with mild to moderate TR, there is a class IIa indication for concomitant TV surgery in the setting of tricuspid annular dilatation.

However, after TV repair, commonly with annuloplasty ring or De Vega annuloplasty, residual TR may still persist and the residual moderate or severe TR have negative impact to right ventricle (RV). It can cause RV dilatation and RV failure(7, 12). Calafiore et al reported 12.4% of significant TR after surgery and the associated factors for the repair failure. If this group of patients developed symptom of RV failure or progressive RV dilatation or dysfunction is detected, they possessed very high-risk for re-operation.

Preoperative transthoracic echocardiography (TTE) is an important tool to classified severity of TR, measured TV annulus, indicate the surgical correction requirement and demonstrate the result of the TR repair. Due to limitation of TTE operator and machine, time-interval between the latest preoperative TTE result and surgery are varied, so the TR severity may already changed. The postoperative TTE result sometimes comes out late after surgery. Therefore, transesophageal echocardiography (TEE), operated by trained cardiac anesthesiologist, may play role to confirm the severity and provide the instant result of the TV repair to help guide the cardiac surgeon to make a decision whether to re-operate in the same setting to improve the surgical outcome.

Therefore, the investigators would like to determine the incidence of residual significant TR by intraoperative TEE in the patients underwent left-side cardiac surgery and the related clinical outcome, including rate of re-admission from cardiac cause and 1- year mortality.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with residual significant tricuspid regurgitation after left-sided cardiac surgery

    • Residual significant tricuspid regurgitation: more than moderate tricuspid regurgitation after corrective surgery
    • Left-sided cardiac surgery: mitral or aortic valve surgery

    Measured: during surgery

Secondary outcomes (4)
  1. Number of patients with different severity of tricuspid regurgitation

    Compare between preoperative trans- thoracic echocardiography and intraoperative transesophageal echocardiography result (before cardiopulmonary bypass initiation)

    Measured: during surgery

  2. Length of stay

    Length of hospital and ICU stay

    Measured: 7 days after surgery

  3. Number of patients require re-operation

    Re-operation for tricuspid regurgitation correction

    Measured: 1 year after surgery

  4. Number of patients require re-admission

    Re-admission due to cardiac cause: right-sided cardiac failure, pulmonary oedema

    Measured: 1 year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start20 Nov 2020
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414358
Sponsor's protocol ID
2020-3
Status last verified
May 2022
First submitted
31 May 2020
Last updated
13 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anyanwu AC, Adams DH. Functional tricuspid regurgitation in mitral valve disease: epidemiology and prognostic implications. Semin Thorac Cardiovasc Surg. 2010 Spring;22(1):69-75. doi: 10.1053/j.semtcvs.2010.05.006.

    PubMed 20813320
  • Hamandi M, George TJ, Smith RL, Mack MJ. Current outcomes of tricuspid valve surgery. Prog Cardiovasc Dis. 2019 Nov-Dec;62(6):463-466. doi: 10.1016/j.pcad.2019.11.014. Epub 2019 Dec 2.

    PubMed 31805294
  • Calafiore AM, Foschi M, Kheirallah H, Alsaied MM, Alfonso JJ, Tancredi F, Gaudino M, Di Mauro M. Early failure of tricuspid annuloplasty. Should we repair the tricuspid valve at an earlier stage? The role of right ventricle and tricuspid apparatus. J Card Surg. 2019 Jun;34(6):404-411. doi: 10.1111/jocs.14042. Epub 2019 Apr 8.

    PubMed 30958905

Questions about this trial

What is this clinical trial studying?

An observational study of Residual Tricuspid Regurgitation and Left-sided Cardiac Surgery, run by Mahidol University at 1 site in Thailand.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 May 2022. 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 Thailand. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with residual significant tricuspid regurgitation after left-sided cardiac surgery (time frame: during surgery). 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 NCT04414358, which also lists 3 linked publications.

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 13 May 2022.

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