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Using heart tests to decide on defibrillator implantation after a heart attack

Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)

Not applicable Interventional Western Sydney Local Health District · NCT03588286

This study tests if using heart tests can help doctors decide when to implant defibrillators in patients with weak hearts after a heart attack to prevent sudden cardiac death.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1058 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorWestern Sydney Local Health District Academic / other
Drugs / interventionsradiation
Locations52 sites (Boston, Massachusetts and 51 other locations)
Trial IDNCT03588286 on ClinicalTrials.gov

What this trial studies

The PROTECT-ICD trial is a multi-centre randomized controlled trial aimed at preventing sudden cardiac death in patients with poor cardiac function following a myocardial infarction. It evaluates the effectiveness of electrophysiology studies (EPS) in guiding the early implantation of implantable cardioverter-defibrillators (ICDs) within the first 40 days post-MI. Additionally, the study assesses the role of cardiac MRI in analyzing cardiac function and predicting arrhythmias. This approach seeks to address the current guidelines that restrict ICD implantation during this critical period despite the high risk of sudden cardiac death.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 85 who are 2-40 days post-myocardial infarction with impaired left ventricular function.

Not a fit: Patients with significant non-cardiac comorbidities, psychiatric illnesses, or those who are not within the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of sudden cardiac death in high-risk patients following a myocardial infarction.

How similar studies have performed: While previous studies have shown mixed results regarding early ICD implantation, this trial explores a novel approach that has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 2-40 days (inclusive) following a myocardial infarct
* Impaired left ventricular systolic function (LVEF≤40% or at least moderately impaired)

Exclusion Criteria:

1. Age \<18 or \>85;
2. Pregnancy;
3. Nursing home resident dependent on one or more activities of daily living;
4. Significant non-cardiac co-morbidity with high likelihood of death within 1 year (this would include any metastatic malignancy, or other terminal disease);
5. Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up;
6. Intravenous drug abuse (ongoing);
7. Unresolved infection associated with risk for hematogenous seeding;
8. Pre-existing implantable cardioverter-defibrillator (ICD);
9. Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded));
10. On the heart transplant list;
11. Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications);\*\*
12. Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)\*\* \*\*NOTE: patients who meet exclusion based on (11) or (12) can be reviewed again in 2-3 days and if symptoms have resolved or treatment performed can be re-considered for inclusion.

Where this trial is running

Boston, Massachusetts and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sudden Cardiac DeathMyocardial Infarction, Sudden Cardiac Death, Electrophysiological Study, Ventricular Tachycardia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.