AnalyST Treadmill Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949000
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : February 23, 2011
Information provided by:
St. Jude Medical

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).

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Device: ICD Implantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators
Study Start Date : July 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Evaluation of start and duration of isoelectric PR intervals [ Time Frame: 4 weeks ]
  2. Evaluation of start and duration of ST intervals [ Time Frame: 4 weeks ]
  3. Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device [ Time Frame: 4 weeks ]
  4. Incidence of ischemic events detected based on the external ECG [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949000

Klinikum Coburg
Coburg, Bavaria, Germany, 96450
Bad Nauheim, Hesse, Germany, 61321
Medizinische Einrichtungen der RWTH Aachen
Aachen, N. Rhin, Germany, 52074
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, N. Rhin, Germany, 67063
Klinikum Luedenscheid
Luedenscheid, N. Rhin, Germany, 58515
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Christian Hamm, Prof. Dr. Kerckhoff-Klinik, Bad Nauheim, Germany

Responsible Party: Prof. Dr. Christian Hamm, Kerckhoff-Klinik Identifier: NCT00949000     History of Changes
Other Study ID Numbers: CR08018HV
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases