AnalyST Treadmill Study

Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators

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 Overview

• Status: Completed
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Device: ICD Implantation

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Coburg, Bavaria, Germany, 96450
      • Klinikum Coburg
  • Hesse
    • Bad Nauheim, Hesse, Germany, 61321
      • Kerckhoff-Klinik
  • N. Rhin
    • Aachen, N. Rhin, Germany, 52074
      • Medizinische Einrichtungen der RWTH Aachen
    • Ludwigshafen, N. Rhin, Germany, 67063
      • Klinikum der Stadt Ludwigshafen am Rhein
    • Luedenscheid, N. Rhin, Germany, 58515
      • Klinikum Luedenscheid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ICD Implant; Implantation of a commercially available AnalyST or AnalyST Accel ICD	Device: ICD Implantation; Implantation of a commercially available AnalyST or AnalyST Accel ICD

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Christian Hamm, Prof. Dr., Kerckhoff-Klinik, Bad Nauheim, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: July 29, 2009
• First Posted (Estimate): July 30, 2009

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: CR08018HV