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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01244308

Acronym

Efface

Enrollment

132

Registered

2010-11-19

Start date

2008-03-31

Completion date

2011-08-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Phrenic nerve stimulation, LV pacing configuration, CRT, Cardiac resynchronisation therapy, Heart failure

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Amount of patients with at least one acceptable LV pacing configuration.	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 \<=2.5V@0.5ms 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.

Countries

Germany

Outcome results