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

NCT03917251 | Withdrawn FDA Device

• 1 other identifier: 0898-18-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Coronary Microvascular Disease; Cardiac Pacemaker Syndrome

Keywords

coronary microvascular dysfunction

Outcome Measures

Primary Outcomes (1)

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

  Microvascular dysfunction with pacing

  Up to 12 months

Secondary Outcomes (1)

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

  Up to 12 months

Study Arms (2)

Right ventricular Pacemaker

OTHER

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

Biventricular Pacemaker

OTHER

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

Coronary flow and pressure measurement in patients with ventricular pacing DIAGNOSTIC_TEST

Coronary flow and pressure measurement in patients with ventricular pacing

Biventricular Pacemaker; Right ventricular Pacemaker

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Nashwa Abdulsalam, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: April 17, 2019
• Study Start: October 7, 2021
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share