Text Size

Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

This study is currently recruiting participants.
Verified January 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00955708
First received: August 4, 2009
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Heart Failure
 Device: ACUITY Spiral LV 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Implants
Patients successfully implanted with the ACUITY Spiral Lead
 Device: ACUITY Spiral LV Lead
The implant of the ACUITY Spiral Lead

  Eligibility

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.

Criteria

Inclusion Criteria:

  • Has been or will be implanted with the ACUITY Spiral Lead within 29 days
  • Is or will be implanted with a BSC commercially available LATITUDE-enabled PG and prescribed the LATITUDE Patient Management system.
  • 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 IRB
  • Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry

Exclusion Criteria:

  • Do not have an appropriate transmission method (e.g. telephone line) compatible with the LATITUDE Communicator
  • Is unable or unwilling to comply with the protocol requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955708

Contacts
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
Investigators
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: January 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013