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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
History of Changes
  Purpose

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


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
All study patients (single arm study)
All eligible patients will be included in the only study arm and will undergo study testing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233323

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

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT01233323     History of Changes
Other Study ID Numbers: DETECT PS
Study First Received: November 2, 2010
Last Updated: September 10, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Work, Health and Social Affairs in North Rhine-Westph
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013