Heart Failure
Conditions
Keywords
Phrenic nerve stimulation, Cardiac Resynchronization Therapy, Heart Failure, Heart Diseases
Brief summary
The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data collection | 3 months follow up | Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation. |
Countries
Germany
Outcome results
None listed