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

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ClinicalTrials.gov Identifier: NCT01233323
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Heart Failure

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study
Study Start Date : February 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Group/Cohort
All study patients (single arm study)
All eligible patients will be included in the only study arm and will undergo study testing.



Primary Outcome Measures :
  1. Data collection [ Time Frame: 3 months follow up ]
    Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with a COGNIS™ CRT-D device
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233323


Locations
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Michael Glikson, MD Heart Institute, Sheba Medical Center, Tel Hashomer, Israël

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01233323     History of Changes
Other Study ID Numbers: DETECT PS
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Boston Scientific Corporation:
Phrenic nerve stimulation
Cardiac Resynchronization Therapy
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases