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Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation

This study is currently recruiting participants.
Verified November 2010 by University of Maryland
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01246947
First received: November 22, 2010
Last updated: November 29, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Surgery
Tricuspid Valve Regurgitation
 Procedure: Tricuspid valve repair
Other: Mitral surgery alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Prospective Randomized Trial of Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Mitral Operation

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • The degree of tricuspid regurgitation at 12 months after surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • NYHA heart failure functional status [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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.


  • NYHA heart failure functional status [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mitral surgery alone
Mitral valve surgery randomization for no repair of the moderate tricuspid regurgitation
 Other: Mitral surgery alone
Randomized to Mitral surgery alone
Other Name: Mitral surgery alone
Active Comparator: Mitral surgery w/Tricuspid valve repair
Mitral valve surgery with randomization to repair the moderate tricuspid regurgitation
 Procedure: Tricuspid valve repair
Randomized to receive Tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques, during Mitral surgery.
Other Name: Tricuspid valve annuloplasty

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246947

Contacts
Contact: James S Gammie, MD 410-328-5842 jgammie@smail.umaryland.edu
Contact: Dana I Beach, BSN 410-328-0993 dbeach2@smail.umaryland.edu

Locations
United States, Maryland
University of Maryland, School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: James S Gammie, MD     410-328-5842     jgammie@smail.umaryland.edu    
Contact: Dana I Beach, BSN     410-328-0993     dbeach2@smail.umaryland.edu    
Principal Investigator: James S Gammie, MD            
Sub-Investigator: Bartley P Griffith, MD            
Sub-Investigator: Jean Jeudy, Jr, MD            
Sub-Investigator: Mehrdad Ghoreishi, MD            
Sponsors and Collaborators
University of Maryland
Edwards Lifesciences
Investigators
Principal Investigator: James S Gammie, MD University of Maryland
  More Information

Publications:

Responsible Party: James Gammie, MD Associate Professor of Medicine, University of Maryland School of Medicine
ClinicalTrials.gov Identifier: NCT01246947     History of Changes
Other Study ID Numbers: HP-00044723
Study First Received: November 22, 2010
Last Updated: November 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Moderate Tricuspid Valve Regurgitation
Tricuspid Valve Repair
Mitral Value Surgery

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013