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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01076361
Registration number
NCT01076361
Ethics application status
Date submitted
24/02/2010
Date registered
26/02/2010
Date last updated
27/10/2014
Titles & IDs
Public title
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
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Scientific title
Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study
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Secondary ID [1]
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4968
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Universal Trial Number (UTN)
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Trial acronym
4968
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arrhythmia
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Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Survival Probability of the Model 4968 Lead Based on Lead-related Complications
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Assessment method [1]
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The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.
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Timepoint [1]
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The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.
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Eligibility
Key inclusion criteria
- Provision of written informed consent and/or authorization for access to and use of
health information by subjects or appropriate legal guardians as required by an
institution's Investigational Review Board, Medical Ethics Board, or Research Ethics
Board
- Availability of implant, follow-up, and product-related event data
- Implanted with a Model 4968 Capsure Epi Lead
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects receiving an implant of a Medtronic lead at a non-participating center and
the implant data and current status cannot be confirmed within 30 days after implant
- Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study
center
- Subjects implanted with a Medtronic cardiac therapy device whose predetermined
enrollment limit for that specific product has been exceeded
- Subjects with exclusion criteria required by local law
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/1999
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2010
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Sample size
Target
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Accrual to date
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Final
370
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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- Bedford Park
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Recruitment postcode(s) [1]
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- Bedford Park
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Recruitment outside Australia
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Alaska
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Colorado
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968
lead. This study is part of the Medtronic System Longevity Study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01076361
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Trial related presentations / publications
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Contacts
Principal investigator
Name
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4968 Clinical Trial Leader
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Address
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Medtronic
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01076361
Download to PDF