Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection "Lung-AF"

Recruiting

Phase N/A Results N/A

Trial Description

Lung resections for pulmonary malignancies offer the best chance of survival for patients, but these procedures carry a significant burden of post-operative morbidity and mortality. Patients are particularly at high risk for post-operative atrial fibrillation (a condition involving irregular heart rhythm). Atrial fibrillation with symptoms can increase the risk of stroke - a blockage in a major blood vessel in the brain, which can potentially result in a disability or even death. The objective of this study is to establish the feasibility of using ambulatory heart rate monitoring to determine the total incidence of atrial fibrillation in the peri-operative period before and after anatomic lung resection for malignancies. The study will also investigate the correlation between atrial fibrillation and rates of stroke and other adverse events, as well as serve to identify the patients that are at a higher risk of developing atrial fibrillation.

Detailed Description

Novel literature suggests that atrial fibrillation that is asymptomatic may just be as problematic as atrial fibrillation that presents itself with symptoms. The objective of the study is to establish the feasibility of tracking the total incidence of atrial fibrillation in the peri-operative period, including both symptomatic and asymptomatic events, using an ambulatory heart monitor. Additionally, the study aims to estimate the overall incidence of peri- and post-operative atrial fibrillation. These will be accomplished through usage of iRhythm ZIO XT, a small pebble shaped device that will be adhered to the patient's chest for 14 days before and after surgery, to measure how often atrial fibrillation occurs.

Conditions

Interventions

  • IRhythm ZIO XT Patch Device
    Intervention Desc: The iRhythm ZIO XT patch is an ECG monitor that has to be worn by study participants. It will be used to track any incidence of atrial fibrillation.
    ARM 1: Kind: Experimental
    Label: iRhythm ZIO XT patch group
    Description: This is the only arm in the study and patients within it will have a small, pebble shaped device adhered to their chests. This is an ECG (electrocardiogram) monitor and will measure the incidence of atrial fibrillation. It will have to be worn for 14 days before and after the lung resection procedure

Trial Design

  • Masking: Open Label
  • Purpose: Screening
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Monthly rate of patient accrual Ongoing from date of study initiation through to sample size completion, estimated to be 12 months No
Primary Patient adherence to monitoring device use-Wear time 28 day time period around lung resection No
Primary Patient adherence to monitoring device use-Logging of symptomatic events 28 day time period around lung resection No
Primary Number of patients who withdraw from study protocol 28 day time period around lung resection No
Secondary Baseline incidence of asymptomatic atrial fibrillation before lung resection Measured from 2 weeks preceding lung resection up to the day of procedure No
Secondary The number of post-operative atrial fibrillation events Measured from post-operative day 1 to 14 days following lung resection No
Secondary The number of any post-operative recurrent atrial fibrillation events within 14 days of lung resection Difference in event rates between the 14 day baseline period before surgery and the 14 day period after surgery No
Secondary Total event rate for asymptomatic atrial fibrillation Comparison of the two intervals of 14 days preceding and 14 days following lung resection No
Secondary Rate of other non- atrial fibrillation arrhythmia Measured from post-operative day 1 to 14 days following lung resection No
Secondary Impact of resection intensity (larger versus smaller resection size) on the development of any atrial fibrillation events Measured from post-operative day 1 to 14 days following lung resection No
Secondary Impact of use of minimally invasive surgery on the development of any atrial fibrillation events Measured from post-operative day 1 to 14 days following lung resection No
Secondary Measurement of the difference of 90 day mortality in event-free patients and those with atrial fibrillation Interval from the date of surgery to up to 90 days after surgery No
Secondary Measurement of the difference of rates of stroke in event-free patients and those with atrial fibrillation Interval from the date of surgery to up to 90 days after surgery No

Sponsors