Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246947
• Other study ID #: HP-00044723
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: February 2017

Study information

• Verified date: June 2017
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All patients 18-65 + older years undergoing mitral valve surgery.

2. 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.

3. All patients referred for mitral valve surgery.

4. Able to understand the consent and able to sign informal consent.

Exclusion Criteria:

1. Patients under 18 years of age.

2. Patient with structural/ organic tricuspid valve disease.

3. Refusal/ Inability to sign informal consent form.

4. Pregnant women.

5. Tricuspid valve endocarditis.

6. 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).

7. Cardiogenic shock at the time of randomization.

8. ST segment elevation myocardial infarction requiring Intervention within 7 days prior to randomization.

9. Evidence of cirrhosis or hepatic synthetic failure.

Related Conditions & MeSH terms

• Cardiac Surgery
• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

Intervention

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

Other:
• Mitral surgery alone
Randomized to Mitral surgery alone

Locations

Country	Name	City	State
United States	University of Maryland, School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Edwards Lifesciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zoghbi WA, Enriquez-Sarano M, Foster E, Grayburn PA, Kraft CD, Levine RA, Nihoyannopoulos P, Otto CM, Quinones MA, Rakowski H, Stewart WJ, Waggoner A, Weissman NJ; American Society of Echocardiography. Recommendations for evaluation of the severity of nat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of tricuspid regurgitation at 12 months after surgery	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.	12 months
Secondary	NYHA heart failure functional status	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.	12 Months
Secondary	NYHA heart failure functional status	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.	24 Months