Status:
COMPLETED
St.Jude Medical Cardiac Lead Assessment Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Externalized Conductors
Visual Lead Anomalies
Eligibility:
All Genders
18+ years
Brief Summary
The Cardiac Lead Assessment Study (CLAS) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 Order PS120111 (August 16, 2012).
Detailed Description
The objective of this study was to determine the prevalence and incidence of externalized conductors and other visual lead anomalies (as evidenced by imaging) and the risk of progression to electrical...
Eligibility Criteria
Inclusion
- Patient has a market released SJM Implantable Cardioverter Defibrillator (ICD), CRT-D or CRT-P already implanted.
- Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1 (see protocol attached.)
- Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
- Are 18 years or above
Exclusion
- Patient is currently pregnant.
- Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
2216 Patients enrolled
Trial Details
Trial ID
NCT01507987
Start Date
March 1 2013
End Date
September 1 2019
Last Update
August 23 2021
Active Locations (45)
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1
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
2
University Hospital of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
3
Heart Center Research
Huntsville, Alabama, United States, 35801
4
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States, 85251