Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
German Society for Thoracic and Cardiovascular Surgery
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai

Brief Summary:

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

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: MVS Alone
Participants will undergo mitral valve surgery alone.
Procedure: MVS
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

Procedure: MVS
MVS will be performed using standard surgical techniques




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. Diuretic Use [ Time Frame: up to 24 Months ]
    The diuretic requirements of patients will be assessed.

  4. Six Minute Walk Test [ Time Frame: up to 24 Months ]
    The total distance walked in six minutes will be assessed.

  5. 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.

  6. Right Ventricular size [ Time Frame: up to 24 Months ]
    Right ventricular (RV) size assessed by echocardiography.

  7. 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.

  8. Peak tricuspid annular velocity [ Time Frame: up to 24 Months ]
    Degree of RV function assessed by peak tricuspid annular velocity

  9. Tricuspid annular peak systolic excursion (TAPSE) [ Time Frame: up to 24 Months ]
    Degree of RV function assessed by TAPSE

  10. Right ventricular fractional area change (RVFAC) [ Time Frame: up to 24 Months ]
    Degree of RV function assessed by RVFAC

  11. Pulmonary Artery Pressure [ Time Frame: up to 24 Months ]
    Pulmonary artery pressure assessed by echocardiography.

  12. Right Ventricular Volume [ Time Frame: up to 24 Months ]
    RV Volume as measured by transthoracic 3D echocardiography.

  13. 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.

  14. 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.

  15. 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.

  16. Survival [ Time Frame: up to 60 Months ]
    Incidence of participants alive

  17. Length of Index Hospitalization [ Time Frame: average 30 days ]
  18. Readmission [ Time Frame: up to 60 months ]
    Incidence of readmissions

  19. Reoperations [ Time Frame: up to 60 months ]
    Incidence of reoperations

  20. Economic Measures (Inpatient costs) [ Time Frame: up to 60 months ]
    Inpatient costs will be measured through the collection of hospital billing.

  21. Serious adverse events [ Time Frame: 60 months ]
    Safety as measured by frequency of serious adverse events.

  22. AV-Block requiring pacemaker implantation [ Time Frame: 60 months ]
    Safety as measured by frequency of AV-Block requiring pacemaker implantation.

  23. New-onset atrial fibrillation [ Time Frame: 60 months ]
    Safety as measured by frequency new-onset atrial fibrillation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing MVS for degenerative MR with (a) Moderate TR as determined by transthoracic 2D echocardiography, or (b) Tricuspid annular dimension ≥ 40 mm (index: ≥21mm/M2 BSA) and trace/mild TR, determined by echocardiography.
  • Age ≥ 18 years
  • Able to sign Informed Consent and Release of Medical Information forms

Exclusion Criteria:

  • Functional MR
  • Evidence of sub-optimal fluid management (e.g., lack of diuretics, weight in excess of dry weight) in the opinion of the cardiology investigator
  • Structural / organic TV disease
  • Severe TV regurgitation as determined by preoperative transthoracic echocardiography (TTE)
  • Implanted pacemaker or defibrillator, where the leads cross the TV from the right atrium into the right ventricle
  • Concomitant cardiac surgery other than atrial fibrillation correction surgery (PVI, Maze, LAA closure), closure of PFO or ASD, or CABG
  • Cardiogenic shock at the time of randomization
  • STEMI requiring intervention within 7 days prior to randomization
  • Evidence of cirrhosis or hepatic synthetic failure
  • Severe, irreversible pulmonary hypertension in the judgment of the investigator
  • Pregnancy at the time of randomization
  • Therapy with an investigational intervention at the time of screening, or plan to enroll patient in additional investigational intervention study during participation in this trial
  • Any concurrent disease with life expectancy < 2 years
  • Unable or unwilling to provide informed consent
  • Unable or unwilling to comply with study follow up in the opinion of the investigator

Information from the National Library of Medicine

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
Locations
Layout table for location information
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
Emory University
Atlanta, Georgia, United States, 30308
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Suburban Hospital
Bethesda, Maryland, United States, 20814
United States, Michigan
University of Michigan Health Services
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
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
Mission Hospital
Asheville, North Carolina, United States, 28801
Duke University
Durham, North Carolina, United States, 27710
WakeMed Clinical Research Institute
Raleigh, North Carolina, United States, 27610
United States, Ohio
Cleveland Clinic
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
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7
Canada, Ontario
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
Canada, Quebec
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
Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Quebec, Canada, G1V 4G5
Germany
Universitares Herzzentrum Hamburg
Berlin, Brandenburg, Germany, 11353
Herzzentrum Leipzig
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
Berlin, Germany
Heart Center, University of Freiburg
Freiburg, Germany
German Heart Center Munich
Munich, Germany
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
German Society for Thoracic and Cardiovascular Surgery
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
Layout table for investigator information
Principal Investigator: Annetine C. Gelijns, PhD Icahn School of Medicine at Mount Sinai
Study Chair: Richard Weisel, MD Toronto General Hospital

Layout table for additonal information
Responsible Party: Annetine Gelijns, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02675244     History of Changes
Other Study ID Numbers: GCO 08-1078-0010
2U01HL088942-07 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:
Tricuspid Valve Regurgitation

Additional relevant MeSH terms:
Layout table for MeSH terms
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases