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
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Condition or disease | Intervention/treatment |
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Heart Failure | Device: ACUITY Spiral Left Ventricular Lead |
Study Type : | Observational |
Actual Enrollment : | 1308 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead |
Actual Study Start Date : | August 4, 2009 |
Actual Primary Completion Date : | February 28, 2018 |
Actual Study Completion Date : | February 28, 2018 |
Group/Cohort | Intervention/treatment |
---|---|
Implants
Patients successfully implanted with the ACUITY Spiral Lead
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Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead |
- 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). ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955708

Study Director: | Olaf Hedrich, MD | Boston Scientific Corporation |
Documents provided by Boston Scientific Corporation:
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00955708 |
Other Study ID Numbers: |
LSR of ACUITY Spiral |
First Posted: | August 10, 2009 Key Record Dates |
Results First Posted: | May 2, 2019 |
Last Update Posted: | May 2, 2019 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Heart Failure Heart Diseases Cardiovascular Diseases |