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Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead

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Trial Conditions
  • Heart Failure
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
0 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Arjun Sharma, MD
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
Device
  • ACUITY Spiral Left Ventricular Lead
For more information about this trial, contact

Michael Orlov

Phone:


Physician Researcher

Investigator Name:

  • Arjun Sharma, MD

Other Information

Sponsor: Boston Scientific Corporation
Phase: Phase 4
Trial ID: NCT00955708
Volunteers:  Not Accepting Healthy Volunteers

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