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

McMaster University

Status: Terminated

Conditions: Atrial Fibrillation; Stroke; Lung Cancer

Treatments: Device: iRhythm ZIO XT patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02547168

SJHH_Lung_AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be at least 18 years of age and competent to consent
• Patients must be diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy
• Patients must have one of: Male gender, age greater than 65, hypertension, obesity, and recent tobacco use within the past year
• Patients must be booked for pneumonectomy, lobectomy or anatomical segmentectomy resection.

Exclusion criteria

• Patients undergoing emergent lung resection

• Patients undergoing lung resection for non-oncologic indications (lung biopsy, bullectomy)

• Patients with an existing neurostimulator

• Patients with pre-existing cardiac disease, defined as:

  • Patients with atrioventricular blockage of any degree or sick sinus syndrome;
  • Patients with known previous atrial fibrillation or flutter lasting more than 1 month;
  • Patients with any persistent diagnosed preoperative arrhythmia
  • Patients with implanted external defibrillators or pacemakers

• Patients with known adhesive allergies

• Inability to comply with or understand ambulatory monitoring.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

iRhythm ZIO XT patch group

Experimental 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

Treatment:

Device: iRhythm ZIO XT patch