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AnalyST Treadmill Study

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00949000
First received: July 29, 2009
Last updated: February 22, 2011
Last verified: February 2011
History of Changes

July 29, 2009
February 22, 2011
July 2009
February 2011   (final data collection date for primary outcome measure)
  • Evaluation of start and duration of isoelectric PR intervals [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluation of start and duration of ST intervals [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Incidence of ischemic events detected based on the external ECG [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00949000 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Ischemic Heart Disease
Device: ICD Implantation
Implantation of a commercially available AnalyST or AnalyST Accel ICD
ICD Implant
Implantation of a commercially available AnalyST or AnalyST Accel ICD
Intervention: Device: ICD Implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2011
February 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00949000
CR08018HV
No
Prof. Dr. Christian Hamm, Kerckhoff-Klinik
St. Jude Medical
Not Provided
Principal Investigator: Christian Hamm, Prof. Dr. Kerckhoff-Klinik, Bad Nauheim, Germany
St. Jude Medical
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP