MitraClip System in Australia and New Zealand (MitraClipANZ)

Abbott

Status: Terminated

Conditions: Mitral Regurgitation

Treatments: Device: MitraClip Implant

Study type: Observational

Funder types: Industry

Identifiers

NCT01301625

Protocol #M10-001

Details and patient eligibility

About

The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.

Full description

The MitraClip System ANZ Clinical Trial is a prospective, observational, single arm, multicenter trial to evaluate the MitraClip device for the treatment of mitral regurgitation (MR). Patients will be enrolled at up to 15 investigational sites throughout Australia and New Zealand. Up to 150 patients will be enrolled. Patients will be considered enrolled when local or general anesthesia is administered for the MitraClip procedure. Patients will be followed at discharge, 30 days, 6 months, 12 months and 24 months.

Investigational sites will recruit consecutive patients who meet trial enrollment criteria. Until enrollment in the MitraClip System ANZ Clinical Trial is closed, all patients who undergo a procedure for placement of a MitraClip device at an investigational site should be enrolled in the MitraClip System ANZ Clinical Trial.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older.
• MR ≥ 3+ .
• Transseptal catheterization and femoral vein access feasible.
• Placement of the MitraClip device on mitral leaflets feasible.
• Mitral valve orifice area ≥ 4.0 cm2.
• Written informed consent obtained.
• The patient agrees to return for follow-up visits.

Exclusion criteria

• Need for emergency surgery, other cardiac surgery.
• Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.
• Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device (VAD).
• Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis or rheumatic disease.
• Transesophageal echocardiography (TEE) contraindicated.
• Known hypersensitivity or contraindication to trial or procedure medications which cannot be managed medically.
• Currently participating in investigational drug trial or another device trial that has not yet completed the primary endpoint or that interferes with the MitraClip System ANZ Clinical Trial.
• Pregnant or planning pregnancy within next 12 months.

Trial design

78 participants in 1 patient group

MitraClip Implant

Description:

Eligible patients undergoing a MitraClip procedure in Australia and New Zealand

Treatment:

Device: MitraClip Implant