Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT06713668
Eligibility Criteria:
Inclusion Criteria:
* Adults (age 18 and older)
* Located in the CVICU
* FDA approved permanent pacemaker in place (inclusive of dual-chamber and Bi-Ventricular ICDs) with labeling that allows backup pacing setting at 100 bpm.
* Receiving a vasopressor or Inotrope for at least 4 hours
* Average HR ≤ 75 bpm over the last hour (on Telemetry review)
* Pulmonary artery catheter in place with functioning thermistor and pulmonary artery port.
Exclusion Criteria:
* Single chamber Implantable Cardiac Defibrillator
* Sinus rhythm with a leadless pacemaker
* Ventricular Tachycardia or Ventricular Fibrillation arrest in last 48 hours
* Hemodynamic instability within the last 4 hours, defined as an increase in the dose of norepinephrine \> 10 mcg/min, an increase of epinephrine \> 10 mcg/kg/min, or initiation of a second vasopressor
* Alternative indication for pacing rate change (i.e Torsade de Pointes, Recurrent Ventricular Tachycardia)
* Comfort-focused care or anticipated death within 24 hours
* Mechanical circulatory support in place
* Newly discovered pacing system malfunction (lead displacement, loss of capture, elevated capture threshold, significant lead impedance change, battery depletion, undersensing or oversensing)
* Non-English Speaking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06713668
Study Brief:
Protocol Section:
NCT06713668