Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection (NCT02547168) | Clinical Trial Compass
TerminatedNot Applicable
Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
Stopped: Trial futility
Canada27 participantsStarted 2017-06-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Monthly rate of patient accrual
Timeframe: Ongoing from date of study initiation through to sample size completion, estimated to be 12 months
2
Patient adherence to monitoring device use-Wear time
Timeframe: 28 day time period around lung resection
3
Patient adherence to monitoring device use-Logging of symptomatic events
Timeframe: 28 day time period around lung resection
4
Number of patients who withdraw from study protocol
Timeframe: 28 day time period around lung resection