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

Not Applicable

Withdrawn

• Conditions: Cardiac Pacemaker Syndrome; Coronary Microvascular Disease
• Interventions: Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing

• Registration Number: NCT03917251
• Lead Sponsor: University of Nebraska

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-03-03
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-17
• Study Start: 2020-12
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Right ventricular Pacemaker	Coronary flow and pressure measurement in patients with ventricular pacing	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.
Biventricular Pacemaker	Coronary flow and pressure measurement in patients with ventricular pacing	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.

Primary Outcome Measures

Name	Time	Method
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR	Up to 12 months	Microvascular dysfunction with pacing

Secondary Outcome Measures

Name	Time	Method
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR	Up to 12 months	Microvascular dysfunction with pacing