AnalyST Treadmill Study
Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators
1 other identifier
interventional
50
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2009
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 4, 2019
February 1, 2019
1.6 years
July 29, 2009
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
ICD Implant
OTHERImplantation of a commercially available AnalyST or AnalyST Accel ICD
Interventions
Implantation of a commercially available AnalyST or AnalyST Accel ICD
Eligibility Criteria
You may qualify if:
- Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD;
- Patient has documented ischemic heart disease.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Klinikum Coburg
Coburg, Bavaria, 96450, Germany
Kerckhoff-Klinik
Bad Nauheim, Hesse, 61321, Germany
Medizinische Einrichtungen der RWTH Aachen
Aachen, N. Rhin, 52074, Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, N. Rhin, 67063, Germany
Klinikum Luedenscheid
Lüdenscheid, N. Rhin, 58515, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Hamm, Prof. Dr.
Kerckhoff-Klinik, Bad Nauheim, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
July 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 4, 2019
Record last verified: 2019-02