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WithdrawnNCT03917251Updated Sep 3, 2024

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

An interventional study of Coronary flow and pressure measurement in patients with ventricular pacing in Coronary Microvascular Disease and Cardiac Pacemaker Syndrome, sponsored by University of Nebraska. Withdrawn. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.

Sponsored by University of Nebraska · Not applicable, Interventional, and Basic science

Why this study was withdrawn
PI left the institution
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Coronary Microvascular Disease
  • Cardiac Pacemaker Syndrome

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Keywords

  • coronary microvascular dysfunction
03

In context

Microvascular Angina

123 studies on the registry are indexed under Microvascular Angina; 36 are open to participants now.

Browse Microvascular Angina studies →

Lead sponsor

University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Right ventricular Pacemaker

    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.

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

  • Other
    Biventricular Pacemaker

    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.

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

Interventions

  • Diagnostic testCoronary flow and pressure measurement in patients with ventricular pacing

    Coronary flow and pressure measurement in patients with ventricular pacing

06

What researchers measure

Primary outcomes

  1. Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR

    Microvascular dysfunction with pacing

    Time frame: Up to 12 months

Secondary outcomes

  1. Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR

    Microvascular dysfunction with pacing

    Time frame: Up to 12 months

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03917251
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Apr 17, 2019
Start date
Oct 7, 2021 (estimated)
Primary completion
Oct 7, 2021
Completion
Oct 7, 2021
Last update
Sep 3, 2024

Study contacts

Nashwa Abdulsalam, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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