Detection of Phrenic Nerve Stimulation Using Sensors' Signals (DETECT PS)

Boston Scientific

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT01233323

DETECT PS

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

All study patients (single arm study)

Description:

All eligible patients will be included in the only study arm and will undergo study testing.