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Trial record 1 of 1 for:    LSR of Acuity - Longitudinal Surveillance Registry of the Acuity™ Spiral Lead
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Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00955708
First received: August 4, 2009
Last updated: February 22, 2017
Last verified: February 2017

August 4, 2009
February 22, 2017
August 2009
December 2022   (Final data collection date for primary outcome measure)
Chronic lead-related complication free rate [ Time Frame: 5 years of follow-up ]
Same as current
Complete list of historical versions of study NCT00955708 on ClinicalTrials.gov Archive Site
Not Provided
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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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1308
December 2022
December 2022   (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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
Puerto Rico
 
NCT00955708
LSR of ACUITY Spiral
No
Not Provided
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Director: Olaf Hedrich, MD Boston Scientific Corporation
Boston Scientific Corporation
February 2017

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