Actively Recruiting

Age: 21Years +
All Genders
NCT05412927

AngelMed Guardian® System PMA Post Approval Study

Led by Angel Medical Systems · Updated on 2025-09-30

500

Participants Needed

18

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

500 Patients (minimum) will be enrolled following commercial implant. Will be treated by their physicians using the standard of care. Standard of care for the Guardian includes an in-office initial programming visit 7-14 days following implant and every 6 months.

CONDITIONS

Official Title

AngelMed Guardian® System PMA Post Approval Study

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 1. Subject has at least one of the following conditions:

    1. Diabetes (Type I or Type II)

    2. Compromised renal function (Cr > 1.2 mg/dl or creatinine clearance less than 50)

    3. TIMI Risk Score of at least 3

      2. Previously diagnosed with a high-risk acute coronary syndrome (e.g., Unstable Angina, STEMI or NSTEMI) or has undergone or is scheduled for CABG within 6 months of implantation.

      3. Has already undergone coronary angiography and revascularization, unless the physician determines it is appropriate to implant before or during the planned procedure.

      4. Lives in a geographic area in close proximity (within approximately 60 minutes by EMS) to any hospital that can treat AMI.

      5. Subjects (men or women) at least 21 years of age. Women of childbearing age must have a negative pregnancy test or confirmation of one of the following:

    <!-- -->
    1. Post-menopause or amenorrhoeic during the past year
    2. Surgical sterilization
    3. Use of effective contraceptive method
Not Eligible

You will not qualify if you...

  • 1. 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.

    2. There is 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.

    3. A permanent pacemaker or ICD is already in place or the subject 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.

    4. Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest.

    5. Subject has recurrent or persistent atrial fibrillation. 6. 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 (LLB, BBB, RBB) or Rate Induced BBB.

    7. Subject has left ventricular hypertrophy evidenced by EKG criteria. 8. 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 or prior central venous access via portacath, Hickman, Groshong, or similar placed in a left pectoral location or left side PICC line.

    9. Subject has 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.

    10. There is evidence of unresolved infection (fever > 38o C and/or leukocytosis > 15,000).

    11. Subject has history of bleeding disorders or severe coagulopathy (platelets < 100,000 plts/ml; APTT or PT > 1.3 x reference range).

    12. Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6 months.

    13. Subject has a potentially fatal disease, such as cancer or refractory congestive heart failure, associated with limitation of life expectancy, which may lead to inadequate compliance to the protocol or confusing data interpretation.

    14. 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.

    15. Subject has previously been implanted with an AngelMed Guardian® System, 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.

    16. Subject has experienced gastro-intestinal hemorrhage in the past 6 months. 17. Subject has any situation in which the use of aspirin is contraindicated for at least 6 months.

    18. Subject has epilepsy. 19. Subject has known severe allergies, e.g., peanut, bee sting, etc. 20. Subject has a known coronary occlusion that cannot be reperfused e.g. known multiple small vessel disease, saphenous vein graft, prior angiography where doctor could not intervene, or jailed occlusion.

AI-Screening

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Trial Site Locations

Total: 18 locations

1

Phoenix Heart

Glendale, Arizona, United States, 85306

Actively Recruiting

2

Arizona Heart & Vascular Clinic

Glendale, Arizona, United States, 85308

Actively Recruiting

3

Southwest Cardiovascular Associates

Mesa, Arizona, United States, 85208

Active, Not Recruiting

4

East Los Angeles Cardiology

Los Angeles, California, United States, 90033

Actively Recruiting

5

Orange County Heart and Research Institute

Orange, California, United States, 92868

Active, Not Recruiting

6

Clermont Ambulatory Surgical Center

Clermont, Florida, United States, 34711

Actively Recruiting

7

Daytona Heart Group

Daytona Beach, Florida, United States, 32114

Actively Recruiting

8

Florida Heart Rhythm Specialists

Fort Lauderdale, Florida, United States, 33308

Actively Recruiting

9

Institute for Cardiovascular Research Studies, Inc.

Miami, Florida, United States, 33176

Actively Recruiting

10

LEJ Medical, LLC

New Smyrna Beach, Florida, United States, 32168

Suspended

11

Northside Hospital Cardiovascular Institute

Atlanta, Georgia, United States, 30342

Actively Recruiting

12

Cardiovascular Associate Research

Covington, Louisiana, United States, 70433

Active, Not Recruiting

13

Heart Clinic of Hammond

Hammond, Louisiana, United States, 70403

Actively Recruiting

14

North Shore Heart and Vascular

Mandeville, Louisiana, United States, 70448

Active, Not Recruiting

15

Corewell Health

Grand Rapids, Michigan, United States, 49503

Active, Not Recruiting

16

South Oklahoma Heart Research

Oklahoma City, Oklahoma, United States, 73135

Actively Recruiting

17

Texan Cardiovascular Institute

El Paso, Texas, United States, 79915

Actively Recruiting

18

Medical City Hospital Forth Worth

Fort Worth, Texas, United States, 76104

Actively Recruiting

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Research Team

J

Jacqueline Finley, BS

CONTACT

S

Sasha John, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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