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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT01233323
First received: November 2, 2010
Last updated: September 10, 2012
Last verified: September 2012

November 2, 2010
September 10, 2012
February 2010
March 2012   (final data collection date for primary outcome measure)
Data collection [ Time Frame: 3 months follow up ] [ Designated as safety issue: No ]
Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.
Same as current
Complete list of historical versions of study NCT01233323 on ClinicalTrials.gov Archive Site
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Detection of Phrenic Nerve Stimulation Using Sensors' Signals
Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study

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

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients implanted with a COGNIS™ CRT-D device

Heart Failure
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All study patients (single arm study)
All eligible patients will be included in the only study arm and will undergo study testing.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01233323
DETECT PS
Not Provided
Guidant Corporation
Guidant Corporation
Not Provided
Principal Investigator: Michael Glikson, MD Heart Institute, Sheba Medical Center, Tel Hashomer, Israël
Guidant Corporation
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP