Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

Boston Scientific

Status: Terminated

Conditions: Heart Failure

Treatments: Device: ACUITY Spiral Left Ventricular Lead

Study type: Observational

Funder types: Industry

Identifiers

NCT00955708

LSR of ACUITY Spiral

Details and patient eligibility

About

The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.

Enrollment: 1,308 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has been or will be implanted with the ACUITY Spiral Lead within 29 days
• Plans to remain in the long-term care of his/her enrolling physician
• Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB)
• Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry

Exclusion criteria

• Is unable or unwilling to comply with the protocol requirements

Trial design

1,308 participants in 1 patient group

Implants

Description:

Patients successfully implanted with the ACUITY Spiral Lead

Treatment:

Device: ACUITY Spiral Left Ventricular Lead