A Study to Assess Blood Flow (Hemodynamics) of Patients with Cardiac Pacemakers

Overview

About this study

The purpose of this study is to determine how changes in pacemaker rate affect systemic hemodynamics, including blood pressure and cardiac output, in acutely ill patients with cardiac pacemakers.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Admitted to either an intensive care unit or progressive care unit with hemodynamic instability or decompensated/end-stage heart failure resulting from an acute medical problem (i.e. primary admission diagnosis is medical).
  • Presence of cardiac pacemaker (including both temporary and permanent devices, as well as implantable defibrillators).
  • Presence of any of the following invasive hemodynamic monitoring devices:
    • Pulmonary artery catheter
    • Arterial catheter
    • Central venous line (including peripherally-inserted central catheters)
  • Stable blood pressure on current vasoactive medical therapy (if required), without need for fluid bolus or adjustment of vasoactive therapy for at least 1 hour.
  • Resting heart rate < 100 bpm.
  • Age > 18 years.

Exclusion Criteria:

  • Inpatient surgery during this hospitalization as the reason for admission (i.e. primary admission diagnosis is surgical).
  • Pacemaker lead or generator dysfunction, including lead fracture or need for battery change within 3 months.
  • Pregnancy.
  • Intra-aortic balloon pump or other percutaneous or surgical circulatory support, including Impella, TandemHeart, peripheral or central veno-arterial extracorporeal membranous oxygenation (ECMO).
  • Hypertrophic Obstructive Cardiomyopathy (HOCM) with resting or inducible left ventricular outflow tract (LVOT) gradient.
  • Amyloid cardiomyopathy.
  • Severe mitral stenosis or severe aortic regurgitation.
  • Not hemodynamically stable to participate in the study at the discretion of the treating physician.
  • Recent (within 1 hour) need for vasoactive medication adjustment or fluid bolus to treat hemodynamic instability; once patients have stabilized from a hemodynamic standpoint, they may be reconsidered for study participation.
  • Recent unstable arrhythmia or requiring intravenous antiarrhythmic drugs.
  • Active/ongoing myocardial ischemia.

The data collected will include the following:

  • Height and weight (body mass index [BMI]).
  • Demographics, medical history, including cardiovascular history and results of previous testing.
  • Medications (outpatient and inpatient).
  • Vital signs.
  • Pacemaker device and lead models.
  • Pacemaker interrogation data.
  • Hemodynamic measurements (see below).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jacob Jentzer, M.D.

Closed for enrollment

Contact information:

Jacob Jentzer M.D.

(507) 255-2398

Jentzer.Jacob@mayo.edu

More information

Publications

Publications are currently not available