Study Stopped
FDA Approval was received for the Model AMSG3-E IMD and therefore commercial implants could be started. There was no longer any need to implant under the CAS. CAS patients were transitioned to commercial patients.
IDE-ALERTS Continued Access Study
ALERTS-CAS
ALERTS Continued Access Study- IDE G060259 Supplement
1 other identifier
interventional
17
1 country
1
Brief Summary
This Continued Access IDE Study includes a subset of former ALERTS trial (NCT00781118) patients and provides performance data for a refined Guardian implantable medical device (AMSG3-E) with a new battery designed to extend device longevity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 20, 2020
CompletedStudy Start
First participant enrolled
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedJune 3, 2022
June 1, 2022
1.3 years
March 12, 2020
June 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Serious Adverse Events (SAE)
Annual rate of SAEs related to the device or procedure
5 years
Study Arms (1)
AngelMed Guardian System
OTHERAll eligible subjects will have the AngelMed Guardian System implanted with alerting features turned ON; receive an external device which provides additional alerting; and receive training on system use.
Interventions
The AngelMed Guardian System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events. The Guardian System is indicated as an adjunct to patient recognized symptoms.
Eligibility Criteria
You may not qualify if:
- Subject (men or women) is at least 21 years of age.
- Women of childbearing age must have a negative pregnancy test or confirmation of one of the following:
- Post-menopause or amenorrhoeic during the past year
- Surgical sterilization
- Use of effective contraceptive method
- In the investigator's opinion, subject lacks ability to respond appropriately to alarms, e.g., illiteracy, poor memory or cognitive function, dementia or other condition affecting memory function, etc.
- Known compromised tissue at the site of lead implantation in the apex of the right ventricle, e.g., prior infarct affecting the RV apex location.
- A permanent pacemaker or ICD is already in place or the patient is indicated for ICD or pacemaker implantation based on the guidelines published by the American College of Cardiology as Class I and IIa recommendations. Class IIb recommendations are at the investigator's discretion.
- Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest.
- Subject has recurrent or persistent atrial fibrillation.
- Subject has recurrent or persistent non-sinus cardiac rhythm, second- or third-degree atrioventricular blocks, QRS duration greater than 120 ms, Benign Early Repolarization (BER), Brugada Syndrome, (LBB, BBB, RBB) or Rate Induced BBB.
- Subject has left ventricular hypertrophy evidenced by EKG criteria.
- Subject has any condition preventing the subcutaneous implantation of the Guardian System in a left pectoral pouch, such as:
- superior vena cava thrombosis,
- subcutaneous tissue deemed inappropriate for the procedure
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orange County Heart Institute and Research Center
Orange, California, 92868, United States
Related Publications (3)
Gibson CM, Holmes D, Mikdadi G, Presser D, Wohns D, Yee MK, Kaplan A, Ciuffo A, Eberly AL 3rd, Iteld B, Krucoff MW. Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Apr 23;73(15):1919-1927. doi: 10.1016/j.jacc.2019.01.014. Epub 2019 Mar 3.
PMID: 30842028RESULTHolmes DR Jr, Krucoff MW, Mullin C, Mikdadi G, Presser D, Wohns D, Kaplan A, Ciuffo A, Eberly AL 3rd, Iteld B, Fischell DR, Fischell T, Keenan D, John MS, Gibson CM. Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events. J Am Coll Cardiol. 2019 Oct 22;74(16):2047-2055. doi: 10.1016/j.jacc.2019.07.084.
PMID: 31623762RESULTKazmi SHA, Datta S, Chi G, Nafee T, Yee M, Kalia A, Sharfaei S, Shojaei F, Mirwais S, Gibson CM. The AngelMed Guardian(R) System in the Detection of Coronary Artery Occlusion: Current Perspectives. Med Devices (Auckl). 2020 Jan 7;13:1-12. doi: 10.2147/MDER.S219865. eCollection 2020.
PMID: 32021496RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell W Krucoff, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 20, 2020
Study Start
September 22, 2020
Primary Completion
January 20, 2022
Study Completion
January 20, 2022
Last Updated
June 3, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share