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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00271180




Registration number
NCT00271180
Ethics application status
Date submitted
28/12/2005
Date registered
30/12/2005
Date last updated
21/11/2018

Titles & IDs
Public title
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Scientific title
Medtronic CRDM Product Performance Report
Secondary ID [1] 0 0
602
Universal Trial Number (UTN)
Trial acronym
PPR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmia 0 0
Bradycardia 0 0
Heart Failure 0 0
Sinus Tachycardia 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
Treatment: Devices - Device

Treatment: Devices: Device


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lead related complications for each lead model. - All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.
Timepoint [1] 0 0
Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive).

Eligibility
Key inclusion criteria
Subjects who meet the following inclusion criteria and do not meet any of the following
exclusion criteria are eligible for enrollment.



• Subject 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 must also apply:

- Subject is indicated for implant or within 30 days post-implant of at least one
Medtronic market-released product used for a pacing, sensing or defibrillation
application

- Subjects who participated in a qualifying study (IDE) of a Medtronic market-released
product with complete implant and follow-up data and subject or appropriate legal
guardian authorizes release of subject study data
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who are, or will be inaccessible for follow-up

- Subjects with exclusion criteria required by local law (EMEA only)

- Subjects receiving an implant of a Medtronic device at a non-participating center and
the implant data and current status cannot be confirmed within 30 days after implant

- Subjects implanted with a Medtronic device whose predetermined enrollment limit for
that specific product has been exceeded

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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North Carolina
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Tennessee
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Vermont
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Virginia
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Washington
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Wisconsin
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Belgium
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Brussel
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Belgium
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Edegem
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Belgium
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Leuven
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Calgary
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Canada
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Kingston
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Canada
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London
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Canada
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Montreal
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Canada
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Canada
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Trois-Rivières
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Neuilly-sur-Seine
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Pessac
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Rennes
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Rouen
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Saint-Priest-en-Jarez
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Toulouse
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Vandoeuvre les Nancy
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Ulm
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Athens
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Ashkelon
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Jerusalem
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Israel
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Ramat Gan
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Bari
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Bologna
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Brescia
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Cotignola
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Italy
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Milano
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Italy
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Pisa
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Italy
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Reggio Emilia
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Japan
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Mitaka
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Shinagawa-Ku
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Japan
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Suita
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Japan
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Yokohama
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Hadiya
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Amsterdam
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Breda
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Leiden
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Christchurch
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Norway
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Bergen
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Trondheim
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Saudi Arabia
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Jeddah
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Saudi Arabia
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Riyadh
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Serbia
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Belgrade
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Toledo
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Skövde
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Uppsala
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Lugano
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Switzerland
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Zürich
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United Kingdom
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Birmingham
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Bristol
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Leeds
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Leicester
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Liverpool
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London
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Manchester
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Middlesbrough
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United Kingdom
State/province [147] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of the Product Performance Report (formerly referred to as System Longevity
Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm
products by analyzing product survival probabilities.
Trial website
https://clinicaltrials.gov/show/NCT00271180
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Product Performance Report Study 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
Medtronic CRM Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
medtroniccrmtrials@medtronic.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00271180