Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
Primary Purpose
Cardiac Surgery, Tricuspid Valve Regurgitation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tricuspid valve repair
Mitral surgery alone
Sponsored by
About this trial
This is an interventional basic science trial for Cardiac Surgery focused on measuring Moderate Tricuspid Valve Regurgitation, Tricuspid Valve Repair, Mitral Value Surgery
Eligibility Criteria
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.
Sites / Locations
- University of Maryland, School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mitral surgery alone
Mitral surgery w/Tricuspid valve repair
Arm Description
Mitral valve surgery randomization for no repair of the moderate tricuspid regurgitation
Mitral valve surgery with randomization to repair the moderate tricuspid regurgitation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01246947
First Posted
November 22, 2010
Last Updated
May 4, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Edwards Lifesciences
1. Study Identification
Unique Protocol Identification Number
NCT01246947
Brief Title
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
Official Title
A Prospective Randomized Trial of Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Mitral Operation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Edwards Lifesciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Tricuspid Valve Regurgitation
Keywords
Moderate Tricuspid Valve Regurgitation, Tricuspid Valve Repair, Mitral Value Surgery
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mitral surgery alone
Arm Type
Active Comparator
Arm Description
Mitral valve surgery randomization for no repair of the moderate tricuspid regurgitation
Arm Title
Mitral surgery w/Tricuspid valve repair
Arm Type
Active Comparator
Arm Description
Mitral valve surgery with randomization to repair the moderate tricuspid regurgitation
Intervention Type
Procedure
Intervention Name(s)
Tricuspid valve repair
Other Intervention Name(s)
Tricuspid valve annuloplasty
Intervention Description
Randomized to receive Tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques, during Mitral surgery.
Intervention Type
Other
Intervention Name(s)
Mitral surgery alone
Intervention Description
Randomized to Mitral surgery alone
Primary Outcome Measure Information:
Title
The degree of tricuspid regurgitation at 12 months after surgery
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
NYHA heart failure functional status
Description
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.
Time Frame
12 Months
Title
NYHA heart failure functional status
Description
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.
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S Gammie, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12835667
Citation
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.
Results Reference
result
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Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
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