Status:

TERMINATED

Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

Lead Sponsor:

Boston Scientific Corporation

Conditions:

Heart Failure

Eligibility:

All Genders

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • Is unable or unwilling to comply with the protocol requirements

Key Trial Info

Start Date :

August 4 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 28 2018

Estimated Enrollment :

1308 Patients enrolled

Trial Details

Trial ID

NCT00955708

Start Date

August 4 2009

End Date

February 28 2018

Last Update

May 2 2019

Active Locations (97)

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Page 1 of 25 (97 locations)

1

Birmingham Heart Clinic

Birmingham, Alabama, United States, 35235

2

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

3

Providence Alaska Medical Center

Anchorage, Alaska, United States, 99508

4

Tri-City Cardiology

Mesa, Arizona, United States, 85206