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

NCT ID: NCT02547168

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2020-08-28

Brief Summary

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

Lung Cancer; Atrial Fibrillation; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

iRhythm ZIO XT patch group

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

Group Type: EXPERIMENTAL

iRhythm ZIO XT patch

Intervention Type: DEVICE

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.

Interventions

iRhythm ZIO XT patch

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster Surgical Associates

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaron Shargall, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

SJHH_Lung_AF

Identifier Type: -

Identifier Source: org_study_id