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NCT Number: NCT01246947

Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation

The mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either fix or replace the valve. Many patients with mitral valve disease also develop a leaky tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart (the right heart pumps blood across the lungs). The amount of leakiness of the tricuspid valve is determined by an ultrasound test, and the amount of leakiness is graded as: none, mild, moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral valve, he or she will fix the tricuspid valve if the tricuspid leakage is severe. This involves sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid valve leakage is only mild (or absent), the surgeon will leave the tricuspid valve alone at the time of mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are uncertain about what to do. In a recent review of thousands of patients across the nation having mitral valve surgery with moderately leaky tricuspid valves, 35 % of patients had tricuspid valve repair. Since the investigators don't know what the best approach is: to leave the moderately leaky tricuspid valve alone or to fix it with a cloth-covered ring, the investigators propose a study to determine which approach is best. Patients having mitral valve surgery with a moderately leaky tricuspid valve will be randomized to either 1. have a tricuspid valve repair or 2. to not have a tricuspid valve repair. The investigators will carefully follow these patients for two years and see if heart function is better among those who got their valve fixed.

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Key information

Conditions

Cardiac Surgery Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency Tricuspid Valve Regurgitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland, School of Medicine

Baltimore, Maryland, 21201, United States

About this study

Study Design:

This is a single-center prospective, randomized controlled clinical trial.

Enroll/Randomize: mitral operation alone, or mitral operation with tricuspid valve repair. Randomization will occur before operation.

Operation: The surgeon will perform mitral surgery and only those patients randomized to tricuspid valve repair will perform tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients 18-65 + older years undergoing mitral valve surgery.
  • Presence of moderate or mild-moderate tricuspid regurgitation as read on any echocardiographic study performed within 6 months prior to operation. Assessment if tricuspid regurgitation will be performed using an integrative method.
  • All patients referred for mitral valve surgery.
  • Able to understand the consent and able to sign informal consent.

Exclusion criteria

  • Patients under 18 years of age.
  • Patient with structural/ organic tricuspid valve disease.
  • Refusal/ Inability to sign informal consent form.
  • Pregnant women.
  • Tricuspid valve endocarditis.
  • Requirement for concomitant cardiac surgery (other than atrial fibrillation correction surgery, closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or coronary artery bypass surgery).
  • Cardiogenic shock at the time of randomization.
  • ST segment elevation myocardial infarction requiring Intervention within 7 days prior to randomization.
  • Evidence of cirrhosis or hepatic synthetic failure.

Treatment and study plan

Tricuspid valve repair

Procedure

Randomized to receive Tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques, during Mitral surgery.

Other names: Tricuspid valve annuloplasty

Mitral surgery alone

Other

Randomized to Mitral surgery alone

Primary outcomes

  1. The degree of tricuspid regurgitation at 12 months after surgery

    Time frame: 12 months

    Standard transthoracic echocardiographic assessment of the degree of tricuspid regurgitation will be performed as described in "Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography" (Zoghbi et al, J Am Soc Echocardiography 2003; 16:777-802).

    An integrative approach will be used, and patients will be categorized as having one of:

    • none/trivial
    • mild
    • moderate
    • severe Tricuspid regurgitation.

Secondary outcomes

  1. NYHA heart failure functional status

    Time frame: 12 Months

    New York Heart Association Classification (NYHA)Class Class I (Asymptomatic)No limitation of ordinary physical activity. Class II (Mild)Slight limitation. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.

    Class III (Moderate)Marked limitation. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.

    Class IV (Severe)Unable to carry out any physical activity without discomfort.

  2. NYHA heart failure functional status

    Time frame: 24 Months

    New York Heart Association Classification (NYHA)Class Class I (Asymptomatic)No limitation of ordinary physical activity. Class II (Mild)Slight limitation. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.

    Class III (Moderate)Marked limitation. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.

    Class IV (Severe)Unable to carry out any physical activity without discomfort.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

A Prospective Randomized Trial of Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Mitral Operation

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Nov 24, 2010
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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