Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study

Heart Failure Clinical Trial

— 4968  

Official title:

Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076361
• Other study ID #: 4968
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: October 24, 2014
• Start date: September 1999
• Est. completion date: September 2010

Study information

• Verified date: October 2014
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Ethics Review CommitteeFrance: Conseil National de l'Ordre des MédecinsGermany: Federal Institute for Drugs and Medical DevicesSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSerbia: Ethics CommitteeAustria: EthikkommissionDenmark: Ethics CommitteeSwitzerland: SwissmedicSwitzerland: EthikkommissionSweden: Regional Ethical Review BoardItaly: Ethics CommitteeAustralia: Human Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Heart Failure

Locations

Country	Name	City	State
United States	Alaska Heart Institute	Anchorage	Alaska

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Former Serbia and Montenegro,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Probability of the Model 4968 Lead Based on Lead-related Complications	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.	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.	No