Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study

Boston Scientific Corporation1 site in 1 country60 target enrollmentFebruary 2010

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Boston Scientific Corporation
Enrollment: 60
Locations: 1
Primary Endpoint: Data collection
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

March 2012

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and capable of providing informed consent and of participating in all testing
•Age 18 or above or of legal age to give informed consent specific to national law
•Implanted with a Boston Scientific COGNIS™ family device
•Geographically stable and is available for follow-up procedures at a study centre

Exclusion Criteria

•Patients that are pacemaker-dependent
•Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion)
•Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry
•Patients who are not expected to support approximately 30 minutes of study testing procedures
•Patients who are not mentally competent enough to provide feedback on PS during study procedures