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OpenTrials
Completed

NCT Number: NCT01244308

Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients

It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.

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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

Medizinische Einrichtungen der RWTH Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • indication for CRT-D implantation / upgrade
  • written informed consent

Exclusion criteria

  • pregnancy
  • age < 18 years
  • patients, who cannot visit the routine follow ups (within first 3.5months)
  • participants to other studies with active treatment arm

Treatment and study plan

Primary outcomes

  1. Amount of patients with at least one acceptable LV pacing configuration.

    Time frame: First Follow Up after hospital discharge (approx. 1-3 months)

    Amount of patients with at least one acceptable, programmable LV pacing configuration. Definition of acceptable LV pacing configuration: LV pacing threshold <[email protected] AND Phrenic nerve threshold is at least twice as high as LV pacing threshold AND LV pacing impedance >=200 Ohms.

    Only patients with implanted CRT-D and bipolar leftventricular lead are taken into account.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in CRT Patients

Acronym: Efface

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Nov 19, 2010
Registry last updated
Feb 4, 2019

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

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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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