Back to resultsAnalyST Treadmill Study
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ICD Implantation
Sponsored by
About this trial
This is an interventional diagnostic trial for Ischemic Heart Disease
Eligibility Criteria
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).
Sites / Locations
- Klinikum Coburg
- Kerckhoff-Klinik
- Medizinische Einrichtungen der RWTH Aachen
- Klinikum der Stadt Ludwigshafen am Rhein
- Klinikum Luedenscheid
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ICD Implant
Arm Description
Implantation of a commercially available AnalyST or AnalyST Accel ICD
Outcomes
Primary Outcome Measures
Evaluation of start and duration of isoelectric PR intervals
Evaluation of start and duration of ST intervals
Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device
Incidence of ischemic events detected based on the external ECG
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00949000
Brief Title
AnalyST Treadmill Study
Official Title
Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICD Implant
Arm Type
Other
Arm Description
Implantation of a commercially available AnalyST or AnalyST Accel ICD
Intervention Type
Device
Intervention Name(s)
ICD Implantation
Intervention Description
Implantation of a commercially available AnalyST or AnalyST Accel ICD
Primary Outcome Measure Information:
Title
Evaluation of start and duration of isoelectric PR intervals
Time Frame
4 weeks
Title
Evaluation of start and duration of ST intervals
Time Frame
4 weeks
Title
Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device
Time Frame
4 weeks
Title
Incidence of ischemic events detected based on the external ECG
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Hamm, Prof. Dr.
Organizational Affiliation
Kerckhoff-Klinik, Bad Nauheim, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Coburg
City
Coburg
State/Province
Bavaria
ZIP/Postal Code
96450
Country
Germany
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
State/Province
Hesse
ZIP/Postal Code
61321
Country
Germany
Facility Name
Medizinische Einrichtungen der RWTH Aachen
City
Aachen
State/Province
N. Rhin
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen
State/Province
N. Rhin
ZIP/Postal Code
67063
Country
Germany
Facility Name
Klinikum Luedenscheid
City
Luedenscheid
State/Province
N. Rhin
ZIP/Postal Code
58515
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
AnalyST Treadmill Study
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