AnalyST Treadmill Study

Abbott

Status: Completed

Conditions: Ischemic Heart Disease

Treatments: Device: ICD Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949000

CR08018HV

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ICD Implant

Other group

Description:

Implantation of a commercially available AnalyST or AnalyST Accel ICD

Treatment:

Device: ICD Implantation