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Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

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ClinicalTrials.gov Identifier: NCT00955708
Recruitment Status : Terminated (Early termination was granted by FDA based on study results meeting the post approval requirements.)
First Posted : August 10, 2009
Results First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Heart Failure Device: ACUITY Spiral Left Ventricular Lead

Study Design
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Study Type : Observational
Actual Enrollment : 1308 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead
Actual Study Start Date : August 4, 2009
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Implants
Patients successfully implanted with the ACUITY Spiral Lead
 Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead


Outcome Measures
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Primary Outcome Measures :
  1. Chronic Left Ventricular Lead-related Complication Free Rate [ Time Frame: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death). ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955708


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Olaf Hedrich, MD Boston Scientific Corporation
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Study Protocol  [PDF] December 6, 2012
Statistical Analysis Plan  [PDF] July 2, 2013

More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00955708    
Other Study ID Numbers: LSR of ACUITY Spiral
First Posted: August 10, 2009    Key Record Dates
Results First Posted: May 2, 2019
Last Update Posted: May 2, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases