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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

Tracking Information
First Submitted Date  ICMJE January 29, 2016
First Posted Date  ICMJE February 5, 2016
Last Update Posted Date April 29, 2019
Actual Study Start Date  ICMJE May 26, 2016
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02675244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Official Title  ICMJE Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Tricuspid Regurgitation
  • Moderate Tricuspid Regurgitation
  • Tricuspid Regurgitation
Intervention  ICMJE
  • Procedure: TV Annuloplasty
    TV Annuloplasty will be performed using standard surgical techniques
  • Procedure: MVS
    MVS will be performed using standard surgical techniques
Study Arms  ICMJE
  • Active Comparator: MVS Alone
    Participants will undergo mitral valve surgery alone.
    Intervention: Procedure: MVS
  • Active Comparator: MVS + TV Annuloplasty
    Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.
    Interventions:
    • Procedure: TV Annuloplasty
    • Procedure: MVS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02675244
Other Study ID Numbers  ICMJE GCO 08-1078-0010
2U01HL088942-07 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Annetine Gelijns, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Annetine C. Gelijns, PhD Icahn School of Medicine at Mount Sinai
Study Chair: Richard Weisel, MD Toronto General Hospital
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP