AnalyST Treadmill Study

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949000
• Other study ID #: CR08018HV
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• ICD Implantation
Implantation of a commercially available AnalyST or AnalyST Accel ICD

Locations

Country	Name	City	State
Germany	Medizinische Einrichtungen der RWTH Aachen	Aachen	N. Rhin
Germany	Kerckhoff-Klinik	Bad Nauheim	Hesse
Germany	Klinikum Coburg	Coburg	Bavaria
Germany	Klinikum der Stadt Ludwigshafen am Rhein	Ludwigshafen	N. Rhin
Germany	Klinikum Luedenscheid	Luedenscheid	N. Rhin

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of start and duration of isoelectric PR intervals		4 weeks
Primary	Evaluation of start and duration of ST intervals		4 weeks
Primary	Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device		4 weeks
Primary	Incidence of ischemic events detected based on the external ECG		4 weeks