AnalyST Treadmill Study

Not Applicable

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Device: ICD Implantation

• Registration Number: NCT00949000
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICD Implant	ICD Implantation	Implantation of a commercially available AnalyST or AnalyST Accel ICD

Primary Outcome Measures

Name	Time	Method
Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device	4 weeks
Evaluation of start and duration of isoelectric PR intervals	4 weeks
Evaluation of start and duration of ST intervals	4 weeks
Incidence of ischemic events detected based on the external ECG	4 weeks

Trial Locations

Locations (5)

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Hesse, Germany

Klinikum Coburg; 🇩🇪 Coburg, Bavaria, Germany

Medizinische Einrichtungen der RWTH Aachen; 🇩🇪 Aachen, N. Rhin, Germany

Klinikum der Stadt Ludwigshafen am Rhein; 🇩🇪 Ludwigshafen, N. Rhin, Germany

Klinikum Luedenscheid; 🇩🇪 Luedenscheid, N. Rhin, Germany