Clinical trial NCT02675244: Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Official title: Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Tricuspid Regurgitation
Moderate Tricuspid Regurgitation
Tricuspid Regurgitation
Keywords: Tricuspid Valve Regurgitation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Canadian Institutes of Health Research (CIHR)
name: German Society for Thoracic and Cardiovascular Surgery
name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2016-02-05
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Percentage of Participants With Treatment Failure
timeFrame: 24 Months
Secondary outcomes:
measure: Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: up to 24 Months
measure: Number of Participants With NYHA Classification I-IV
timeFrame: at 24 Months
measure: Diuretic Use
timeFrame: 24 Months
measure: Six Minute Walk Test
timeFrame: 24 Months
measure: Number of Participants With Degree of TR
timeFrame: up to 24 Months
measure: Right Ventricular Size
timeFrame: 24 Months
measure: Number of Participants With Normal RV Function
timeFrame: up to 24 Months
measure: Peak Tricuspid Annular Velocity
timeFrame: 24 Months
measure: Tricuspid Annular Peak Systolic Excursion (TAPSE)
timeFrame: 24 Months
measure: Right Ventricular Fractional Area Change (RVFAC)
timeFrame: 24 Months
measure: Pulmonary Artery Pressure
timeFrame: up to 24 Months
measure: Right Ventricular Volume
timeFrame: 24 Months
measure: SF-12
timeFrame: 24 Months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 24 Months
measure: EuroQoL (EQ-5D)
timeFrame: 24 Months
measure: Survival
timeFrame: up to 60 Months
measure: Length of Index Hospitalization
timeFrame: average 30 days
measure: Number of Participants With Readmission
timeFrame: up to 24 months
measure: Number of Participants With TV Reoperations
timeFrame: up to 24 months
measure: Economic Measures (Inpatient Costs)
timeFrame: up to 60 months
measure: Number of Participants With Serious Adverse Events
timeFrame: 24 months
measure: Gait Speed Test
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine - Yale-New Haven Hospital
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Columbia
country: United States
facility: MedStar Health
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health Services
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Einstein Heart Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Hospital
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Clinical Research Institute
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
city: Berlin
country: Germany
facility: Universitares Herzzentrum Hamburg
state: Brandenburg
city: Berlin
country: Germany
facility: Herzzentrum Leipzig
state: Brandenburg
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hesse-Nassau
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
state: Lower Saxony
city: Jena
country: Germany
facility: University Medical Center Jena
state: Thuringia
city: Bad Oeynhausen
country: Germany
facility: HDZ NRW Bad Oeynhausen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Freiburg
country: Germany
facility: Heart Center, University of Freiburg
city: Munich
country: Germany
facility: German Heart Center Munich
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Annetine C. Gelijns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto General Hospital
name: Richard Weisel, MD
role: STUDY_CHAIR
References:
citation: Gammie JS, Chu MWA, Falk V, Overbey JR, Moskowitz AJ, Gillinov M, Mack MJ, Voisine P, Krane M, Yerokun B, Bowdish ME, Conradi L, Bolling SF, Miller MA, Taddei-Peters WC, Jeffries NO, Parides MK, Weisel R, Jessup M, Rose EA, Mullen JC, Raymond S, Moquete EG, O'Sullivan K, Marks ME, Iribarne A, Beyersdorf F, Borger MA, Geirsson A, Bagiella E, Hung J, Gelijns AC, O'Gara PT, Ailawadi G; CTSN Investigators. Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation. N Engl J Med. 2022 Jan 27;386(4):327-339. doi: 10.1056/NEJMoa2115961. Epub 2021 Nov 13.