Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation

NCT01246947 | Completed DMC

• 1 other identifier: HP-00044723
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery; Tricuspid Valve Regurgitation

Keywords

Moderate Tricuspid Valve Regurgitation; Tricuspid Valve Repair; Mitral Value Surgery

Outcome Measures

Primary Outcomes (1)

• 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: 1. none/trivial 2. mild 3. moderate 4. severe Tricuspid regurgitation.

  12 months

Secondary Outcomes (2)

• NYHA heart failure functional status

  12 Months

• NYHA heart failure functional status

  24 Months

Study Arms (2)

Mitral surgery alone

ACTIVE COMPARATOR

Mitral valve surgery randomization for no repair of the moderate tricuspid regurgitation

Other: Mitral surgery alone

Mitral surgery w/Tricuspid valve repair

ACTIVE COMPARATOR

Mitral valve surgery with randomization to repair the moderate tricuspid regurgitation

Procedure: Tricuspid valve repair

Interventions

Tricuspid valve repair PROCEDURE

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

Also known as: Tricuspid valve annuloplasty

Mitral surgery w/Tricuspid valve repair

Mitral surgery alone OTHER

Randomized to Mitral surgery alone

Mitral surgery alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

University of Maryland, School of Medicine

Baltimore, Maryland, 21201, United States

Location

Related 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 native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr. 2003 Jul;16(7):777-802. doi: 10.1016/S0894-7317(03)00335-3. No abstract available.

  PMID: 12835667 RESULT

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• James S Gammie, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 24, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 8, 2023

Record last verified: 2017-06

Locations

US (1)