Acute Coronary SyndromeALERTS-CASNCT04316481
IDE-ALERTS Continued Access Study
A study testing AngelMed Guardian System in people with Acute Coronary Syndrome, run by Angel Medical Systems at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- AngelMed Guardian System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Heart Institute and Research Center
Orange, California, 92868
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- AngelMed Guardian System
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngelMed Guardian SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AngelMed Guardian System | Other | 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. Receives: Device: AngelMed Guardian System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Serious Adverse Events (SAE)
Annual rate of SAEs related to the device or procedure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start22 Sep 2020
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Continued Access
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angel Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell W Krucoff, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316481
- Sponsor's protocol ID
- WRB 1281733
- Acronym
- ALERTS-CAS
- Status last verified
- Jun 2022
- First submitted
- 12 Mar 2020
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 30842028Holmes 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.
PubMed 31623762Kazmi 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.
PubMed 32021496
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALERTS Continued Access Study- IDE G060259 Supplement
- ClinicalTrials.gov ID
- NCT04316481
- Acronym / sponsor ID
- ALERTS-CAS / WRB 1281733
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Angel Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Continued Access
| Arm | Type | Receives |
|---|---|---|
| AngelMed Guardian System | Other | Device: AngelMed Guardian SystemAll 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngelMed Guardian SystemThe 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. | Device | AngelMed Guardian System |
Primary outcome
Rate of Serious Adverse Events (SAE)
Time frame: 5 years
Annual rate of SAEs related to the device or procedure
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Results publication: PubMed 30842028Gibson 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.
- Results publication: PubMed 31623762Holmes 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.
- Results publication: PubMed 32021496Kazmi 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.
- SSEDLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell W Krucoff, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AngelMed Guardian System in people with Acute Coronary Syndrome, run by Angel Medical Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Serious Adverse Events (SAE) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316481, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.