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AnalyST Treadmill Study

This study has been completed.
Information provided by:
St. Jude Medical Identifier:
First received: July 29, 2009
Last updated: February 22, 2011
Last verified: February 2011
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 Intervention
Ischemic Heart Disease Device: ICD Implantation

Study Type: Interventional
Study Design: 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

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Prof. Dr. Christian Hamm, Kerckhoff-Klinik Identifier: NCT00949000     History of Changes
Other Study ID Numbers: CR08018HV
Study First Received: July 29, 2009
Last Updated: February 22, 2011

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases processed this record on September 20, 2017