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NCT03850808 · ClinicalTrials.gov registry record

LV Dysfunction Following Pacemaker Placement

A clinical trial, sponsored by Oregon Health and Science University.

Completed
Registry status
500
Enrollment target

NCT03850808: Completed study, sponsored by Oregon Health and Science University.

NCT03850808 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 500 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03850808 has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
500 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2013-09
Est. Completion 2018-09

What the finished NCT03850808 record still lists

NCT03850808 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT03850808 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03850808 about?

NCT03850808 is a clinical study titled "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...

What is the current status of trial NCT03850808?

This trial is currently completed. The enrollment target is 500 participants. The study started on 2013-09. Estimated completion is 2018-09.

Who is sponsoring clinical trial NCT03850808?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03850808, the US trial registry maintained by the National Library of Medicine. NCT03850808 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.