Back to resultsDetermining the True Incidence of Atrial Fibrillation Before and After Lung Resection (Lung-AF)
Primary Purpose
Lung Cancer, Atrial Fibrillation, Stroke
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iRhythm ZIO XT patch
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring Atrial Fibrillation, Symptomatic Atrial Fibrillation, Asymptomatic Atrial Fibrillation, Lung Resection, Ambulatory Cardiac Monitor
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.
Sites / Locations
- St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iRhythm ZIO XT patch group
Arm 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
Outcomes
Primary Outcome Measures
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
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.
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.
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.
Secondary Outcome Measures
Baseline incidence of asymptomatic atrial fibrillation before lung resection
Number of unknown/asymptomatic/occult atrial fibrillation in the high-risk malignant lung resection population before surgery so that we know whether any differences in the event rate after surgery are likely to be as a result of the surgery itself. This will be measured by having patients wear the iRhythm ZIO XT patch for the 2 weeks before surgery
The number of post-operative atrial fibrillation events
Number of symptomatic and asymptomatic atrial fibrillation cases that occurred within 14 days of lung resection surgery, automatically measured by the iRhythm ZIO patch device for 2 weeks from the day after surgery
The number of any post-operative recurrent atrial fibrillation events within 14 days of lung resection
To compare the difference in post-operative atrial fibrillation rates between those who experienced any atrial fibrillation pre- and intra-operatively (recurrent atrial fibrillation) with those who did not as measured by a comparison of the two 14 day readings assessed by the iRhythm ZIO XT patch device.
Total event rate for asymptomatic atrial fibrillation
Number of asymptomatic atrial fibrillation events during the 28 day monitoring period, adjudicated by cardiology consultation of the ZIO XT patch output
Rate of other non- atrial fibrillation arrhythmia
Number of non- atrial fibrillation arrhythmias during the 14-day post-discharge time interval following lung resection, adjudicated by cardiology consultation of the ZIO XT patch output
Impact of resection intensity (larger versus smaller resection size) on the development of any atrial fibrillation events
Measure whether there is a difference in the number of recurrent, asymptomatic and/or symptomatic atrial fibrillation events depending on the amount of lung tissue removed as part of the resection, measured as per review of surgical characteristics noted in patient records
Impact of use of minimally invasive surgery on the development of any atrial fibrillation events
Measure whether there is a difference in the number of recurrent, asymptomatic and/or symptomatic atrial fibrillation events depending on whether an open or a minimally invasive technique was used to complete resection, measured as per review of surgical characteristics noted in patient records
Measurement of the difference of 90 day mortality in event-free patients and those with atrial fibrillation
Number of deaths within 90 days of surgery, comparing between event-free and peri-operative atrial fibrillation sub-cohorts as determined by patient chart review
Measurement of the difference of rates of stroke in event-free patients and those with atrial fibrillation
Number of strokes in untreated patients in the 30 and 90 day follow up periods, comparing between event-free and peri-operative atrial fibrillation cohorts as measured by the validated Questionnaire for Verifying Stroke-Free Status (QVSFS)
Full Information
NCT ID
NCT02547168
First Posted
September 1, 2015
Last Updated
February 23, 2021
Sponsor
McMaster University
Collaborators
McMaster Surgical Associates
1. Study Identification
Unique Protocol Identification Number
NCT02547168
Brief Title
Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
Acronym
Lung-AF
Official Title
Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Trial futility
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
August 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
McMaster Surgical Associates
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Atrial Fibrillation, Stroke
Keywords
Atrial Fibrillation, Symptomatic Atrial Fibrillation, Asymptomatic Atrial Fibrillation, Lung Resection, Ambulatory Cardiac Monitor
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iRhythm ZIO XT patch group
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
iRhythm ZIO XT patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Monthly rate of patient accrual
Description
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
Time Frame
Ongoing from date of study initiation through to sample size completion, estimated to be 12 months
Title
Patient adherence to monitoring device use-Wear time
Description
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.
Time Frame
28 day time period around lung resection
Title
Patient adherence to monitoring device use-Logging of symptomatic events
Description
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.
Time Frame
28 day time period around lung resection
Title
Number of patients who withdraw from study protocol
Description
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.
Time Frame
28 day time period around lung resection
Secondary Outcome Measure Information:
Title
Baseline incidence of asymptomatic atrial fibrillation before lung resection
Description
Number of unknown/asymptomatic/occult atrial fibrillation in the high-risk malignant lung resection population before surgery so that we know whether any differences in the event rate after surgery are likely to be as a result of the surgery itself. This will be measured by having patients wear the iRhythm ZIO XT patch for the 2 weeks before surgery
Time Frame
Measured from 2 weeks preceding lung resection up to the day of procedure
Title
The number of post-operative atrial fibrillation events
Description
Number of symptomatic and asymptomatic atrial fibrillation cases that occurred within 14 days of lung resection surgery, automatically measured by the iRhythm ZIO patch device for 2 weeks from the day after surgery
Time Frame
Measured from post-operative day 1 to 14 days following lung resection
Title
The number of any post-operative recurrent atrial fibrillation events within 14 days of lung resection
Description
To compare the difference in post-operative atrial fibrillation rates between those who experienced any atrial fibrillation pre- and intra-operatively (recurrent atrial fibrillation) with those who did not as measured by a comparison of the two 14 day readings assessed by the iRhythm ZIO XT patch device.
Time Frame
Difference in event rates between the 14 day baseline period before surgery and the 14 day period after surgery
Title
Total event rate for asymptomatic atrial fibrillation
Description
Number of asymptomatic atrial fibrillation events during the 28 day monitoring period, adjudicated by cardiology consultation of the ZIO XT patch output
Time Frame
Comparison of the two intervals of 14 days preceding and 14 days following lung resection
Title
Rate of other non- atrial fibrillation arrhythmia
Description
Number of non- atrial fibrillation arrhythmias during the 14-day post-discharge time interval following lung resection, adjudicated by cardiology consultation of the ZIO XT patch output
Time Frame
Measured from post-operative day 1 to 14 days following lung resection
Title
Impact of resection intensity (larger versus smaller resection size) on the development of any atrial fibrillation events
Description
Measure whether there is a difference in the number of recurrent, asymptomatic and/or symptomatic atrial fibrillation events depending on the amount of lung tissue removed as part of the resection, measured as per review of surgical characteristics noted in patient records
Time Frame
Measured from post-operative day 1 to 14 days following lung resection
Title
Impact of use of minimally invasive surgery on the development of any atrial fibrillation events
Description
Measure whether there is a difference in the number of recurrent, asymptomatic and/or symptomatic atrial fibrillation events depending on whether an open or a minimally invasive technique was used to complete resection, measured as per review of surgical characteristics noted in patient records
Time Frame
Measured from post-operative day 1 to 14 days following lung resection
Title
Measurement of the difference of 90 day mortality in event-free patients and those with atrial fibrillation
Description
Number of deaths within 90 days of surgery, comparing between event-free and peri-operative atrial fibrillation sub-cohorts as determined by patient chart review
Time Frame
Interval from the date of surgery to up to 90 days after surgery
Title
Measurement of the difference of rates of stroke in event-free patients and those with atrial fibrillation
Description
Number of strokes in untreated patients in the 30 and 90 day follow up periods, comparing between event-free and peri-operative atrial fibrillation cohorts as measured by the validated Questionnaire for Verifying Stroke-Free Status (QVSFS)
Time Frame
Interval from the date of surgery to up to 90 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaron Shargall, MD FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
We'll reach out to this number within 24 hrs