AnalyST Treadmill Study

Abbott Medical Devices50 enrolled

Overview

The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ischemic Heart Disease

Interventions

ICD ImplantationDEVICE

Implantation of a commercially available AnalyST or AnalyST Accel ICD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD; * Patient has documented ischemic heart disease. Exclusion Criteria: * Patient has an indication for ventricular pacing; * Patient has chronotropic incompetence or insufficiency; * Patient has a contraindication to stress testing; * Patient is physically unable to complete the stress test protocol; * The patient has persistent or permanent atrial fibrillation (AF); * Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason; * Patient is pregnant; * Patient is minor (\< 18 years old).

Locations (5)

Klinikum Coburg

Coburg, Bavaria, Germany

Kerckhoff-Klinik

Bad Nauheim, Hesse, Germany

Medizinische Einrichtungen der RWTH Aachen

Aachen, N. Rhin, Germany

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen, N. Rhin, Germany

Outcomes

Primary Outcomes

Evaluation of start and duration of isoelectric PR intervals

Time frame: 4 weeks

Evaluation of start and duration of ST intervals

Time frame: 4 weeks

Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device

Time frame: 4 weeks

Incidence of ischemic events detected based on the external ECG

Time frame: 4 weeks

Data from ClinicalTrials.gov

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