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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01076348




Registration number
NCT01076348
Ethics application status
Date submitted
24/02/2010
Date registered
26/02/2010
Date last updated
27/02/2019

Titles & IDs
Public title
Model 4965 Post-Approval Study
Scientific title
Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study
Secondary ID [1] 0 0
4965
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Pacing 0 0
Bradycardia 0 0
Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Model 4965 Complication Free Rate - A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- Subjects or appropriate legal guardians provide written informed consent and/or
authorization for access to and use of health information, as required by an
institution's IRB/MEC/REB

AND one of the following (A, B, or C) must also apply:

A. Subjects indicated for implant or within six months post-implant of a Medtronic
market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic
lead must be used for a pacing, sensing, or defibrillation application.

B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product
and for whom:

- product is market-released

- complete implant and follow-up data, including product-related adverse events, are
available

- subject or appropriate legal guardian authorizes release of subject study data to SLS
C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a
minimum of three pre-selected sites to retrospectively collect data for post approval
requirements. Post approval requirements indicate 50 adult subjects implanted with a
model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The
study plans to enroll approximately 100 subjects with a model 4965 lead and
approximately 200 subjects with a model 4968 lead.

Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic
Systems Study will continue in the follow-up phase of the SLS.
Minimum age
19 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 SLS 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 (EMEA only)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
New Hampshire
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
State/province [24] 0 0
North Carolina
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Ohio
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Oregon
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Pennsylvania
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United States of America
State/province [28] 0 0
South Carolina
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United States of America
State/province [29] 0 0
South Dakota
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United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
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United States of America
State/province [32] 0 0
Vermont
Country [33] 0 0
United States of America
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Virginia
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United States of America
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Washington
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United States of America
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Wisconsin
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Austria
State/province [36] 0 0
Linz
Country [37] 0 0
Austria
State/province [37] 0 0
Vienna
Country [38] 0 0
Belgium
State/province [38] 0 0
Hasselt
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Canada
State/province [42] 0 0
Saskatchewan
Country [43] 0 0
Denmark
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Copenhagen
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France
State/province [44] 0 0
Marseille
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Germany
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Homburg/Saar
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Italy
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Catanzaro
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Italy
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Reggio Emilia
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Italy
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Udine
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Netherlands
State/province [49] 0 0
Eindhoven
Country [50] 0 0
Netherlands
State/province [50] 0 0
Rotterdam
Country [51] 0 0
Serbia
State/province [51] 0 0
Belgrad
Country [52] 0 0
Spain
State/province [52] 0 0
Valencia
Country [53] 0 0
Sweden
State/province [53] 0 0
Skovde
Country [54] 0 0
Switzerland
State/province [54] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted
within Medtronic's System Longevity Study (SLS).
Trial website
https://clinicaltrials.gov/show/NCT01076348
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
4965 Post-Approval Study Clinical Trial Leader
Address 0 0
Medtronic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications