LV Dysfunction Following Pacemaker Placement

Several studies have confirmed the link between chronic RV apical pacing and the development of heart failure and LV systolic dysfunction in some patients 1,2. However, questions continue to remain unanswered in regard to the adverse effects of RV pacing such as the exact amount of RV pacing that is detrimental to cardiac function and which subsets of patients are most at risk for developing cardiac dysfunction from chronic RV pacing. Rates of permanent pacemaker implantation have been increased over the last twenty years with expanding indications to include permanent pacing after AV node ablation for the treatment of drug refractory atrial fibrillation and other atrial tachy-arrhythmias. The current standard of practice is to minimize RV pacing however in patients that have had an AV node ablation right ventricular pacing cannot be avoided therefore it is important to identify if this particular group of patients is at an increased risk for developing worsening cardiac function. The purpose of this study is to compare cardiac function over time between patients that have undergone AV node ablation versus patients that have had pacemaker implantation for AV node dysfunction.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

Study Design This is a retrospective chart review of patients that have undergone permanent pacemaker implantation by the electrophysiology group at Oregon Health and Sciences University Hospital during the period between 01/2003 and 01/2013 for chronic RV pacing after AV node ablation or for AV node dysfunction.

Goal The goal of this study is to determine if patients requiring RV pacing after AV nodal ablation are at increased risk for developing worsening cardiac function secondary to chronic RV pacing compared to patients requiring RV pacing for AV node dysfunction.

Specific Objectives

To determine the number of patients that have a permanent pacemaker implanted after AV node ablation and for AV node dysfunction within the last 10 years at OHSU Hospital.
To determine the number of patients that have a biventricular pacemaker implanted with or without an implantable cardiac defibrillator within the last 10 years at OHSU Hospital (control group).
Amongst those patients identified determine (1) left ventricular ejection fraction prior to permanent pacemaker or biventricular pacemaker implantation and over time (2) left ventricular volume and/or diameter prior to permanent pacemaker placement and over time (3) all cause mortality
Amongst those patients identified determine incidence of new onset atrial fibrillation after permanent pacemaker or biventricular pacemaker implantation
Amongst those patients identified determine incidence of inpatient admission of heart failure exacerbation defined as presenting symptoms of dyspnea, orthopnea, paroxysmal nocturnal dyspnea, increased lower extremity edema requiring IV diuretics

Methods

This is a retrospective chart review of patients that have undergone permanent pacemaker medical record system used at OHSU Hospital) with the help of an EPIC representative. If the patient was referred for permanent pacemaker or biventricular pacemaker implantation from a physician or medical group outside of OHSU records will be requested from that physician or medical group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who have undergone permanent pacemaker placement for AV node dysfunction.

Exclusion criteria

retrospective--n/a

Treatment and study plan

Primary outcomes

Left Ventricular Systolic Function

Time frame: 3 month and 1 year followup, if available (this is a chart review)

This is a chart review to see if left ventricular systolic function changed after placement of a permanent pacemaker. Changed is defined as 10 percentage points of left ventricular ejection fraction.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

The Incidence of Left Ventricular Dysfunction Following Pacemaker Placement: Differential Effects of Intrinsic AV Node Disease v. AV Node Ablation.

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Feb 22, 2019
Registry last updated: Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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