View Clinical Trial (Medical Research Study)

4968 Post-approval Study - NCT01076361-(Clinical Trial 563895)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Milwaukee
State:  
WI
Zip Code:
Conditions: Arrhythmia - Heart Failure
Purpose: The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead.
Study summary: The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.
Criteria: 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 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
Study is available at:
Milwaukee, WI
United States

Primary Contact:
4968 Clinical Trial Leader
Email: medtronicCRMtrials@medtronic.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.