NCT03850808|Completed
LV Dysfunction Following Pacemaker Placement
The Incidence of Left Ventricular Dysfunction Following Pacemaker Placement: Differential Effects of Intrinsic AV Node Disease v. AV Node Ablation.
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The Incidence of Left Ventricular Dysfunction Following Pacemaker Placement: Differential Effects of Intrinsic AV Node Disease v. AV Node Ablation.
Sponsor study identifier
observational
500
1 country
1
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2018
Actual (reported)Study Completion
September 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 25, 2013
Actual (reported)September 2018
Actual (reported)September 2018
Actual (reported)February 22, 2019
Actual (reported)Left Ventricular Systolic Function
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.
3 month and 1 year followup, if available (this is a chart review)
This group will be patients in whom a decline in left ventricular systolic function was found.
This group will consist of patients in whom left ventricular systolic function is preserved.
Patients who have undergone permanent pacemaker placement for AV node dysfunction
Contact the study team to confirm eligibility.
Oregon Health & Science University
Portland, Oregon, 97239, United States
Charles Henrikson, MD
Oregon Health and Science University
500 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2013
First Posted
February 22, 2019
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
MultiPoint Pacing IDE Study
Primary Completion
September 2018
Actual (reported)Study Completion
September 2018
Actual (reported)Last Updated
February 25, 2019
Record last verified: 2019-02
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