Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment fortify® st, fortify assura® st, ellipse® st family of devices
Phase phase 3
Sponsor St. Jude Medical
Start date August 2011
End date June 2016
Trial size 5228 participants
Trial identifier NCT01424722, CRD_420

Summary

This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
fortify® st, fortify assura® st, ellipse® st family of devices ST Monitoring Feature
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.

Primary Outcomes

Measure
Percent of patients who experience a false positive ST detection in 12 months FU
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Eligible patients will meet all of the following: 1. Have an indication for an ICD implantation or pulse generator change 2. Have documented coronary artery disease. Documented coronary artery disease is defined as having at least one of the following present a) evidence of a prior MI on ECG and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or ST-T wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography. 3. Willing and able to comply with protocol requirements, including keeping all required visits 4. Willing to participate in the study and able to sign an IRB approved informed consent form 5. Be at least 18 years of age when enrolled in the study Exclusion Criteria: - Patients will be excluded if they meet any of the following: 1. Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time) 2. Have NYHA Class IV Heart Failure 3. Have persistent or permanent atrial fibrillation 4. Have a known history of intermittent Bundle Branch Block 5. Pregnant or planning a pregnancy during the study participation 6. Have a life expectancy of < 1 year due to any condition 7. Are currently participating in a clinical investigation that includes an active treatment arm.

Additional Information

Official title ST Monitoring to Detect ACS Events in ICD Patients
Principal investigator Michael Gibson, MD
Description This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by St. Jude Medical.