Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02675244|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2016
Last Update Posted : April 29, 2019
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not.
At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.
|Condition or disease||Intervention/treatment||Phase|
|Mild Tricuspid Regurgitation Moderate Tricuspid Regurgitation Tricuspid Regurgitation||Procedure: TV Annuloplasty Procedure: MVS||Not Applicable|
The tricuspid valve controls the flow of blood in your heart between the right ventricle and the right atrium. TR is a condition where the valve does not close fully when it is supposed to and blood can then leak back into the right atrium. When TR becomes severe, surgery is usually performed to correct it. The purpose of the research is to determine whether repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned mitral valve surgery, would improve the heart health of those who receive it compared to those who do not. There are no new or "experimental" procedures being tested in this study: both the mitral valve procedure and the tricuspid valve repair procedure are well established surgeries and are regularly performed together in patients who have severe TR. The available evidence addressing this issue is not definite: it is based on less rigorous methods of investigation, and the results have been conflicting. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about what surgical treatment is best for patients with your condition.
This study will enroll people scheduled for mitral valve surgery with mild to moderate tricuspid regurgitation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery|
|Actual Study Start Date :||May 26, 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2023|
Active Comparator: MVS Alone
Participants will undergo mitral valve surgery alone.
MVS will be performed using standard surgical techniques
Active Comparator: MVS + TV Annuloplasty
Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.
Procedure: TV Annuloplasty
TV Annuloplasty will be performed using standard surgical techniques
MVS will be performed using standard surgical techniques
- Degree of TR Repair [ Time Frame: 24 Months ]Effectiveness of TR Repair assessed by a composite of death, reoperation for TR, or progression of TR from baseline by two grades or the presence of severe TR at 24 months.
- MACCE [ Time Frame: up to 24 Months ]Major Adverse Cardiac and Cerebrovascular Events (MACCE) is defined as a non-weighted composite score comprised of the following components: Death, Stroke, and Serious heart failure events
- NYHA Classification [ Time Frame: up to 24 Months ]Functional status will be assessed by the New York Heart Association (NYHA) Classification scale which ranges from 1 (no physical limitations) to 4 (severe limitation of physical activity).
- Diuretic Use [ Time Frame: up to 24 Months ]The diuretic requirements of patients will be assessed.
- Six Minute Walk Test [ Time Frame: up to 24 Months ]The total distance walked in six minutes will be assessed.
- Degree of TR [ Time Frame: up to 24 Months ]Degree of TR assessed by echocardiography, categorized according to American Society of Echocardiography guidelines as none/mild/moderate/severe.
- Right Ventricular size [ Time Frame: up to 24 Months ]Right ventricular (RV) size assessed by echocardiography.
- Degree of RV function [ Time Frame: up to 24 Months ]Degree of RV function assessed by echocardiography as normal, mildly impaired, moderately impaired, severely impaired.
- Peak tricuspid annular velocity [ Time Frame: up to 24 Months ]Degree of RV function assessed by peak tricuspid annular velocity
- Tricuspid annular peak systolic excursion (TAPSE) [ Time Frame: up to 24 Months ]Degree of RV function assessed by TAPSE
- Right ventricular fractional area change (RVFAC) [ Time Frame: up to 24 Months ]Degree of RV function assessed by RVFAC
- Pulmonary Artery Pressure [ Time Frame: up to 24 Months ]Pulmonary artery pressure assessed by echocardiography.
- Right Ventricular Volume [ Time Frame: up to 24 Months ]RV Volume as measured by transthoracic 3D echocardiography.
- SF-12 [ Time Frame: up to 24 Months ]Quality of Life assessed by SF-12. A measure of perceived health (health-related quality of life [QoL]) that describes the degree of general physical health status and mental health distress. Higher scores indicate higher levels of health.
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: up to 24 Months ]Quality of Life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life, in which higher scores reflect better health status.
- EuroQoL (EQ-5D) [ Time Frame: up to 24 Months ]Quality of Life assessed by EuroQoL (EQ-5D) - a standardised instrument for use as a measure of health outcome. Higher scores indicate higher levels of health.
- Survival [ Time Frame: up to 60 Months ]Incidence of participants alive
- Length of Index Hospitalization [ Time Frame: average 30 days ]
- Readmission [ Time Frame: up to 60 months ]Incidence of readmissions
- Reoperations [ Time Frame: up to 60 months ]Incidence of reoperations
- Economic Measures (Inpatient costs) [ Time Frame: up to 60 months ]Inpatient costs will be measured through the collection of hospital billing.
- Serious adverse events [ Time Frame: 60 months ]Safety as measured by frequency of serious adverse events.
- AV-Block requiring pacemaker implantation [ Time Frame: 60 months ]Safety as measured by frequency of AV-Block requiring pacemaker implantation.
- New-onset atrial fibrillation [ Time Frame: 60 months ]Safety as measured by frequency new-onset atrial fibrillation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675244
Hide Study Locations
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Connecticut|
|Yale University School of Medicine - Yale-New Haven Hospital|
|New Haven, Connecticut, United States, 06520-8039|
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Bethesda, Maryland, United States, 20814|
|United States, Michigan|
|University of Michigan Health Services|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03766|
|United States, New York|
|Montefiore Einstein Heart Center|
|Bronx, New York, United States, 10467|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Asheville, North Carolina, United States, 28801|
|Durham, North Carolina, United States, 27710|
|WakeMed Clinical Research Institute|
|Raleigh, North Carolina, United States, 27610|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Baylor College of Medicine|
|Houston, Texas, United States|
|Baylor Research Institute|
|Plano, Texas, United States, 75093|
|United States, Virginia|
|University of Virginia Health Systems|
|Charlottesville, Virginia, United States, 22908|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G2B7|
|London Health Sciences|
|London, Ontario, Canada, N6A 5A5|
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Centre Hospitalier de l'Université de Montréal|
|Montreal, Quebec, Canada, H2W 1T8|
|Hôpital du Sacré-Cœur de Montréal|
|Montreal, Quebec, Canada, H4J 1C5|
|Institut Universitaire de Cardiologie de Quebec (Hopital Laval)|
|Quebec, Canada, G1V 4G5|
|Universitares Herzzentrum Hamburg|
|Berlin, Brandenburg, Germany, 11353|
|Berlin, Brandenburg, Germany, 13347|
|University Medical Center Göttingen|
|Göttingen, Lower Saxony, Germany|
|University Medical Center Jena|
|Jena, Thuringia, Germany|
|HDZ NRW Bad Oeynhausen|
|Bad Oeynhausen, Germany|
|Deutsches Herzzentrum Berlin|
|Heart Center, University of Freiburg|
|German Heart Center Munich|
|Principal Investigator:||Annetine C. Gelijns, PhD||Icahn School of Medicine at Mount Sinai|
|Study Chair:||Richard Weisel, MD||Toronto General Hospital|