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Trial record 1 of 1 for:    NCT00955708
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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

Tracking Information
First Submitted Date August 4, 2009
First Posted Date August 10, 2009
Results First Submitted Date July 10, 2018
Results First Posted Date May 2, 2019
Last Update Posted Date May 2, 2019
Actual Study Start Date August 4, 2009
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2019)
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). ]
Original Primary Outcome Measures
 (submitted: August 7, 2009)
Chronic lead-related complication free rate [ Time Frame: 5 years of follow-up ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Surveillance Registry (LSR) of ACUITY Spiral
Official Title Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The population will be a broad base representative of those recieving the ACUITY Spiral lead.
Condition Heart Failure
Intervention Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead
Study Groups/Cohorts Implants
Patients successfully implanted with the ACUITY Spiral Lead
Intervention: Device: ACUITY Spiral Left Ventricular Lead
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 22, 2017)
1308
Original Estimated Enrollment
 (submitted: August 7, 2009)
1700
Actual Study Completion Date February 28, 2018
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number NCT00955708
Other Study ID Numbers LSR of ACUITY Spiral
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor Boston Scientific Corporation
Collaborators Not Provided
Investigators
Study Director: Olaf Hedrich, MD Boston Scientific Corporation
PRS Account Boston Scientific Corporation
Verification Date July 2018