- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316481
IDE-ALERTS Continued Access Study (ALERTS-CAS)
June 1, 2022 updated by: Angel Medical Systems
ALERTS Continued Access Study- IDE G060259 Supplement
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This Continued Access IDE Study is a prospective, non-randomized, multi-center (up to 25 sites) study designed to provide performance assessment of a refined Guardian implantable medical device (AMSG3-E) through controlled access of a replacement Guardian System to a subset of former ALERTS patients while waiting for FDA approval of the AMSG3-E.
The AMSG3-E contains a drop-in replacement battery designed to extend the life of the implant to potentially exceed the previous 3-years implant life.
Eligible patients will include those that exited the ALERTS study and chose to leave the device and/or lead in place.
Eligible patients must also continue to meet ALERTS inclusion criteria and not have developed any exclusion criteria since exiting the ALERTS study.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Orange, California, United States, 92868
- Orange County Heart Institute and Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria (all must be true):
- Subject previously participated in the ALERTS study and currently has either a Guardian System IMD plus IS-1 lead or IS-1 lead still in place and hasn't developed exclusion criteria.
- 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
Exclusion Criteria:
- 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
- prior central venous access via portacath, Hickman, Groshong, or similar placed in a left pectoral location or left side PICC line.
- Extremely heavy alcohol consumption (participates in binge drinking that leads to alcohol intoxication) or has history of alcohol or illicit drug abuse within past 5 years.
- Evidence of unresolved infection (fever > 38o C and/or leukocytosis > 15,000).
- History of bleeding disorders or severe coagulopathy (platelets < 100,000 plts/ml; APTT or PT > 1.3 x reference range).
- Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6 months.
- Subject has other severe diseases, such as cancer or refractory congestive heart failure, associated with limitation of life expectancy (less than 1 year), which may lead to inadequate compliance to the protocol or confusing data interpretation.
- Subject has clinical conditions such as heart diseases, difficult-to-control blood pressure, difficult-to-control insulin-dependent diabetes or serious prior infections attributed to the diabetes, or others that, at the investigator's discretion, could seriously affect the subject's current clinical condition during study procedures.
- Subject has current participation or previous participation in another drug or device study in the past 30 days that conflicts with this study as determined by the study sponsor.
- Gastro-intestinal hemorrhage in the past 6 months.
- Subject has any situation in which the use of aspirin is contraindicated for at least 6 months.
- Subject has epilepsy
- Subject has known severe allergies, e.g., peanut, bee sting.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: AngelMed Guardian System
All 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Serious Adverse Events (SAE)
Time Frame: 5 years
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Annual rate of SAEs related to the device or procedure
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mitchell W Krucoff, MD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Holmes 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.
- Kazmi 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 22, 2020
Primary Completion (ACTUAL)
January 20, 2022
Study Completion (ACTUAL)
January 20, 2022
Study Registration Dates
First Submitted
March 12, 2020
First Submitted That Met QC Criteria
March 18, 2020
First Posted (ACTUAL)
March 20, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 3, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WRB 1281733
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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