Trial record 1 of 1 for:    NCT00955708
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Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00955708
First received: August 4, 2009
Last updated: July 14, 2014
Last verified: July 2014

August 4, 2009
July 14, 2014
August 2009
December 2021   (final data collection date for primary outcome measure)
Chronic lead-related complication free rate [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00955708 on ClinicalTrials.gov Archive Site
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Longitudinal Surveillance Registry (LSR) of ACUITY Spiral
Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The population will be a broad base representative of those recieving the ACUITY Spiral lead.

Heart Failure
Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead
Implants
Patients successfully implanted with the ACUITY Spiral Lead
Intervention: Device: ACUITY Spiral Left Ventricular Lead
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1700
December 2021
December 2021   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Jill Leigh jill.leigh@bsci.com
Contact: Clinical Study Helpdesk 1-800-CARDIAC cshd@bsci.com
United States,   Puerto Rico
 
NCT00955708
LSR of ACUITY Spiral
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Director: Arjun Sharma, MD Boston Scientific Corporation
Boston Scientific Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP