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

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

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.

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.

Published trials that share one or more normalized conditions with this study.

Completed