Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Tricuspid Regurgitation Clinical Trial

Official title:

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02675244
• Other study ID #: GCO 08-1078-0010
• Secondary ID: 2U01HL088942-07
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 26, 2016
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 401
• Est. completion date: April 2024
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 none/trace or mild TR, determined by echocardiography.
• Age = 18 years
• Able to sign Informed Consent and Release of Medical Information forms
• "Degenerative mitral valve disease refers to a spectrum of conditions in which morphologic changes in the connective tissues of the mitral valve cause structural lesions . . ., such as chordal elongation, chordal rupture, leaflet tissue expansion, and annular dilation typically resulting in mitral regurgitation due to leaflet prolapse." This definition excludes rheumatic heart disease. (Anyanwu AC, Adams DH. (2007) Etiological classification of degenerative mitral valve disease: Barlow's disease and fibroelasticity deficiency. Semin Thorac Cardiovasc Surg; 19(2): 90-6).

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

Related Conditions & MeSH terms

• Mild Tricuspid Regurgitation
• Moderate Tricuspid Regurgitation
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Procedure:
• TV Annuloplasty
TV Annuloplasty will be performed using standard surgical techniques
• MVS
MVS will be performed using standard surgical techniques

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	London Health Sciences	London	Ontario
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Hôpital du Sacré-Cœur de Montréal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Institut Universitaire de Cardiologie de Quebec (Hopital Laval)	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Germany	HDZ NRW Bad Oeynhausen	Bad Oeynhausen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Herzzentrum Leipzig	Berlin	Brandenburg
Germany	Universitares Herzzentrum Hamburg	Berlin	Brandenburg
Germany	University Hospital Frankfurt	Frankfurt	Hesse-Nassau
Germany	Heart Center, University of Freiburg	Freiburg
Germany	University Medical Center Göttingen	Göttingen	Lower Saxony
Germany	University Medical Center Jena	Jena	Thuringia
Germany	German Heart Center Munich	Munich
United States	University of Michigan Health Services	Ann Arbor	Michigan
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	Suburban Hospital	Bethesda	Maryland
United States	Montefiore Einstein Heart Center	Bronx	New York
United States	University of Virginia Health Systems	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	MedStar Health	Columbia	Maryland
United States	Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Yale University School of Medicine - Yale-New Haven Hospital	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Research Institute	Plano	Texas
United States	WakeMed Clinical Research Institute	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Stanford University School of Medicine	Stanford	California
United States	Stony Brook Hospital	Stony Brook	New York

Sponsors (5)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Canadian Institutes of Health Research (CIHR), Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), German Society for Thoracic and Cardiovascular Surgery, National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment Failure	The primary outcome of this trial is treatment failure defined as the composite of (1) death from any cause, (2) reoperation for TR, (3) presence of severe TR at two years post randomization or, for patients enrolled with less than moderate TR and annular dilatation, progression by two grades (i.e., from none/trace TR to moderate TR) at two years post randomization.	24 Months
Secondary	Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)	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	up to 24 Months
Secondary	Number of Participants With NYHA Classification I-IV	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).; Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.; Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.; Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.; No NYHA class listed or unable to determine	at 24 Months
Secondary	Diuretic Use	The diuretic requirements of patients will be assessed.	24 Months
Secondary	Six Minute Walk Test	The total distance, in feet, walked in six minutes	24 Months
Secondary	Number of Participants With Degree of TR	Degree of TR assessed by echocardiography, categorized according to American Society of Echocardiography guidelines as none/mild/moderate/severe.	up to 24 Months
Secondary	Right Ventricular Size		24 Months
Secondary	Number of Participants With Normal RV Function	Number of Participants with Normal RV Function assessed by echocardiography.	up to 24 Months
Secondary	Peak Tricuspid Annular Velocity		24 Months
Secondary	Tricuspid Annular Peak Systolic Excursion (TAPSE)	Degree of RV function assessed by TAPSE	24 Months
Secondary	Right Ventricular Fractional Area Change (RVFAC)	Degree of RV function assessed by RVFAC	24 Months
Secondary	Pulmonary Artery Pressure	Pulmonary artery pressure assessed by echocardiography.	up to 24 Months
Secondary	Right Ventricular Volume	RV Volume as measured by transthoracic 3D echocardiography.	24 Months
Secondary	SF-12	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. The physical and mental health scores on the 12-Item Short Form Survey (SF-12) are reported as T scores (mean, 50±10, 50 indicates the population mean with a standard deviation of 10), with higher scores indicating better health status.	24 Months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)	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. Scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary range from 0 to 100, with higher scores indicating a better quality of life and fewer symptoms and physical limitations associated with heart failure.	24 Months
Secondary	EuroQoL (EQ-5D)	Quality of Life assessed by EuroQoL (EQ-5D) - a standardised instrument for use as a measure of health outcome. Scores on the EuroQol (EQ-5D) visual analogue scale range from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate higher levels of health.	24 Months
Secondary	Survival	Incidence of participants alive	up to 60 Months
Secondary	Length of Index Hospitalization		average 30 days
Secondary	Number of Participants With Readmission	Incidence of readmissions	up to 24 months
Secondary	Number of Participants With TV Reoperations	Number of participants with TV reoperations	up to 24 months
Secondary	Economic Measures (Inpatient Costs)	Inpatient costs will be measured through the collection of hospital billing.	up to 60 months
Secondary	Number of Participants With Serious Adverse Events	Safety as measured by frequency of serious adverse events.	24 months
Secondary	Gait Speed Test	Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks	24 months