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

NCT02547168 | Terminated FDA Device

• 1 other identifier: SJHH_Lung_AF
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Atrial Fibrillation; Stroke

Keywords

Atrial Fibrillation; Symptomatic Atrial Fibrillation; Asymptomatic Atrial Fibrillation; Lung Resection; Ambulatory Cardiac Monitor

Outcome Measures

Primary Outcomes (4)

• Monthly rate of patient accrual

  Proportion of patients who are determined to be eligible for study relative to the number of patients actually enrolled and consented for participation in the study. This will help to inform the willingness of patients to participate in this study

  Ongoing from date of study initiation through to sample size completion, estimated to be 12 months

• Patient adherence to monitoring device use-Wear time

  Patient adherence to the device attachment requirements as stated in the study protocol, defined as the device remaining in place for at least 90% of the expected 28 day patch period (14 days before surgery and 14 days after) to determine feasibility of the study protocol in clinical context and patient tolerability. This will be measured by the iRhythm ZIO XT patch output.

  28 day time period around lung resection

• Patient adherence to monitoring device use-Logging of symptomatic events

  Patient adherence to the symptomatic atrial fibrillation event logging task as stated in the study protocol, defined as the successful manual triggering of the device by the patient to note at least 80% of symptomatic events over the expected 28 day patch period (14 days before surgery and 14 days after) to determine feasibility of the study protocol in clinical context and patient tolerability. This will be measured by the iRhythm ZIO XT patch output.

  28 day time period around lung resection

• Number of patients who withdraw from study protocol

  Number of patients who choose to withdraw from the study, defined as those who fail to complete the 14-day baseline monitoring period before surgery, decline to wear the device post-operatively, or drop out partway through the 14-day post-operative monitoring period. This will be measured by ongoing discussion with the patient and will help to determine the feasibility of the study protocol in clinical context and patient tolerability.

  28 day time period around lung resection

Secondary Outcomes (9)

• Baseline incidence of asymptomatic atrial fibrillation before lung resection

  Measured from 2 weeks preceding lung resection up to the day of procedure

• The number of post-operative atrial fibrillation events

  Measured from post-operative day 1 to 14 days following lung resection

• 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

• Total event rate for asymptomatic atrial fibrillation

  Comparison of the two intervals of 14 days preceding and 14 days following lung resection

• Rate of other non- atrial fibrillation arrhythmia

  Measured from post-operative day 1 to 14 days following lung resection

Study Arms (1)

iRhythm ZIO XT patch group

EXPERIMENTAL

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

Device: iRhythm ZIO XT patch

Interventions

iRhythm ZIO XT patch 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.

iRhythm ZIO XT patch group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• McMaster Surgical Associates: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Yaron Shargall, MD FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 11, 2015
• Study Start: June 2, 2017
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)