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
  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:


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 April 17, 2014