The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics

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University of Nebraska

Status

Withdrawn

Conditions

Coronary Microvascular Disease
Cardiac Pacemaker Syndrome

Treatments

Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT03917251
0898-18-FB

Details and patient eligibility

About

The study will examine role of transvenous pacing on coronary microcirculation.

Full description

To study the role of transvenous pacing on the coronary microcirculation. This will be accomplished by gathering data from invasive Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) with and without ventricular pacing.

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All patients 19 years of age or older with clinical evidence of coronary ischemia undergoing coronary angiogram, and who have a pacemaker.

Exclusion criteria

  • Acute ST segment myocardial infarction
  • Known sensitivity or contraindication to the agents planned for administration during coronary angiography
  • Pacemaker dependent patients
  • Pregnancy
  • Hypotension (a systolic blood pressure lower than 90mmHg) that would preclude the administration of adenosine
  • Severe renal dysfunction, defined as a estimated glomerular filtration (eGFR) less than 30ml/min, confirmed by recent testing
  • Study subject has any underlying disorder that, in the opinion of the investigator, precludes them from giving informed consent at the time of enrollment

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Right ventricular Pacemaker
Other group
Description:
Patients with right ventricular pacing and evidence of coronary ischemia who have evidence of coronary ischemia who are to undergo coronary angiogram.When an intermediate stenosis (40-80%) has been identified angiographically, this lesion will undergo further hemodynamic assessment, All data including resting flow, FFR, CFR, vital signs, arrhythmias and patient symptoms will be recorded twice: once when the pacemaker is programmed to pace, and once when the PPM is reprogrammed such that the pacemaker is no longer pacing.
Treatment:
Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing
Biventricular Pacemaker
Other group
Description:
Patients with Biventricular pacing and evidence of coronary ischemia who have evidence of coronary ischemia who are to undergo coronary angiogram.When an intermediate stenosis (40-80%) has been identified angiographically, this lesion will undergo further hemodynamic assessment, All data including resting flow, FFR, CFR, vital signs, arrhythmias and patient symptoms will be recorded twice: once when the pacemaker is programmed to pace, and once when the PPM is reprogrammed such that the pacemaker is no longer pacing.
Treatment:
Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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