Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
First received: August 4, 2009
Last updated: November 10, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Heart Failure
Device: ACUITY Spiral Left Ventricular Lead
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Chronic lead-related complication free rate [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1700
Study Start Date: August 2009
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients successfully implanted with the ACUITY Spiral Lead
Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will be a broad base representative of those recieving the ACUITY Spiral lead.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955708

Contact: Jill Leigh jill.leigh@bsci.com
Contact: Clinical Study Helpdesk 1-800-CARDIAC cshd@bsci.com

  Show 99 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Study Director: Arjun Sharma, MD Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00955708     History of Changes
Other Study ID Numbers: LSR of ACUITY Spiral 
Study First Received: August 4, 2009
Last Updated: November 10, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 09, 2016