Evaluating the benefit of concurrent tricuspid valve repair during mitral surgery (CTSN-TVR-DZHK14)

ID

NCT02675244

Status

Closed

DZG

DZHK

Start date

05/26/2016

Contact

Contacts
  • Volkmar Falk
  • Annetine C. Gelijns

Parameters

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