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OpenTrials
Completed

NCT Number: NCT00949000

AnalyST Treadmill Study

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).

Completed

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Coburg, Coburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ICD implantation

Device

Implantation of a commercially available AnalyST or AnalyST Accel ICD

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 30, 2009
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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