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Completed

NCT Number: NCT01233323

Detection of Phrenic Nerve Stimulation Using Sensors' Signals

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum Berlin

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Data collection

    Time frame: 3 months follow up

    Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study

Acronym: DETECT PS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 3, 2010
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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