Longitudinal Surveillance Registry (LSR) of ACUITY Spiral
This study is currently recruiting participants.
Verified January 2013 by Boston Scientific Corporation
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00955708
First received: August 4, 2009
Last updated: January 10, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 4, 2009 | ||||||||
| Last Updated Date | January 10, 2013 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Estimated Primary Completion Date | December 2019 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Chronic lead-related complication free rate [ Time Frame: 5 years of follow-up ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00955708 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Longitudinal Surveillance Registry (LSR) of ACUITY Spiral | ||||||||
| Official Title ICMJE | 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 LV Lead. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| 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. |
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| Condition ICMJE | Heart Failure | ||||||||
| Intervention ICMJE | Device: ACUITY Spiral LV Lead
The implant of the ACUITY Spiral Lead |
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| Study Group/Cohort (s) | Implants
Patients successfully implanted with the ACUITY Spiral Lead
Intervention: Device: ACUITY Spiral LV Lead |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1700 | ||||||||
| Estimated Completion Date | December 2019 | ||||||||
| Estimated Primary Completion Date | December 2019 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Puerto Rico | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00955708 | ||||||||
| Other Study ID Numbers ICMJE | LSR of ACUITY Spiral | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Boston Scientific Corporation | ||||||||
| Study Sponsor ICMJE | Boston Scientific Corporation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Boston Scientific Corporation | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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