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

Abbott Medical Devices132 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

132

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Medizinische Einrichtungen der RWTH Aachen

Aachen, Germany

Hufeland Klinikum GmbH

Bad Langensalza, Germany

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, Germany

Outcomes

Primary Outcomes

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

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.

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

Data from ClinicalTrials.gov

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