Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Tricuspid Insufficiency; Tricuspid Regurgitation

Treatments: Device: Transcatheter Tricuspid Valve Repair

Study type: Observational

Funder types: Industry

Identifiers

NCT03779490

2017-21

Details and patient eligibility

About

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.

Full description

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market Clinical Follow up Study.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  • Eighteen (18) years of age or older
  • Moderate or greater functional Tricuspid Regurgitation (TR)
  • Patient is eligible to receive the Edwards Cardioband TR System per the current approved indications for use.

• Exclusion Criteria:

  • Patients deemed anatomically unsuitable for the device by echocardiography
  • Patients in whom transesophageal echocardiography (TEE) is contraindicated
  • Previous tricuspid valve repair or replacement
  • Severe aortic, mitral and / or pulmonic valve stenosis
  • Severe aortic, mitral and / or pulmonic valve regurgitation
  • Renal Insufficiency requiring dialysis or severe kidney renal disease
  • Life expectancy of less than twelve months
  • Patient is pregnant or lactating