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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:
ClinicalTrials.gov Identifier:
NCT00955708
First Posted: August 10, 2009
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
August 4, 2009
August 10, 2009
November 14, 2017
August 4, 2009
December 2017   (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
Not Provided
Not Provided
Not Provided
 
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
July 2018
December 2017   (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
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Director: Olaf Hedrich, MD Boston Scientific Corporation
Boston Scientific Corporation
November 2017