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Clinical Trials/NCT00940888
NCT00940888CompletedNot Applicable

SJ4 Post Approval Study

Abbott Medical Devices1 site in 1 country1,701 target enrollmentStarted: June 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,701
Locations
1
Primary Endpoint
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
  • •Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.

Exclusion Criteria

  • •Be currently participating in a clinical investigation that includes an active treatment arm.
  • •Have a life expectancy of less than 6 months due to any condition.
  • •Be less than 18 years of age.

Outcomes

Primary Outcomes

Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector

Time Frame: 5 years

Right Ventricle (RV) Bipolar Capture Thresholds

Time Frame: 5 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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