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Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification (TRAC)

S

San Donato Group (GSD)

Status

Enrolling

Conditions

Tricuspid Regurgitation Congenital

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The aims of this study are:

  1. to explore a novel 2D-Cardiovascular magnetic resonance (CMR) indirect method for tricuspid regurgitation (TR) quantification (ATRIAL method) relying on right atrium variables, and assess its agreement with the traditional indirect method (involving right ventricle variables) and the direct method (based on through-plane phase contrast (PC) sequences on the tricuspid valve);
  2. to assess the agreement of TR volume (RVol) and regurgitant fraction quantification from 2D-CMR methods with transthoracic echocardiography and 4DF-CMR methods;
  3. to assess the diagnostic performance of 2D-CMR in classifying TR, in terms of RVol and regurgitant fraction, with respect to echocardiographic transthoracic echocardiography grades.

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients aged ≥ 18 years with the diagnosis of al least mild-degree tricuspid regurgitation, who:
  • patients that are scheduled for a Cardiovascular Magnetic Resonance examination in our Institution

Exclusion criteria

  • Patients with previous surgical or transcatheter interventions on the tricuspid valve
  • Patients with Ebstein's disease
  • Subjects with pace-maker or intracardiac defibrillator
  • Subjects with intrabody ferromagnetic material precluding patient's safety
  • Patients with claustrophobia or breath-holding precluding an adequate CMR images quality
  • Pregnant women

Trial contacts and locations

1

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Central trial contact

Giulia Pasqualin, MD

Data sourced from clinicaltrials.gov

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