Detection of Phrenic Nerve Stimulation Using Sensors' Signals

Completed

• Conditions: Heart Failure

• Registration Number: NCT01233323
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data collection	3 months follow up	Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.

Trial Locations

Locations (1)

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany