Status:
COMPLETED
Detection of Phrenic Nerve Stimulation Using Sensors' Signals
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01233323
Start Date
February 1 2010
End Date
March 1 2012
Last Update
February 3 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Deutsches Herzzentrum Berlin
Berlin, Germany