Lung CancerLung-AFNCT02547168
Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
A study testing iRhythm ZIO XT patch in people with Lung Cancer and Atrial Fibrillation, run by McMaster University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Atrial Fibrillation, Stroke
- What is being tested?
- iRhythm ZIO XT patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jun 2017to 28 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- iRhythm ZIO XT patch
- Keywords
- Atrial Fibrillation, Symptomatic Atrial Fibrillation, Asymptomatic Atrial Fibrillation, Lung Resection, Ambulatory Cardiac Monitor
- Medical subject headings
- Lung Neoplasms, Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRhythm ZIO XT patchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: iRhythm ZIO XT patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 day time period around lung resection
Secondary outcomes (9)
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
Measured: Measured from 2 weeks preceding lung resection up to the day of procedure
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
Measured: 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
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.
Measured: 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
Number of asymptomatic atrial fibrillation events during the 28 day monitoring period, adjudicated by cardiology consultation of the ZIO XT patch output
Measured: Comparison of the two intervals of 14 days preceding and 14 days following lung resection
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
Measured: Measured from post-operative day 1 to 14 days following lung resection
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
Measured: Measured from post-operative day 1 to 14 days following lung resection
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
Measured: Measured from post-operative day 1 to 14 days following lung resection
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
Measured: Interval from the date of surgery to up to 90 days after surgery
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)
Measured: Interval from the date of surgery to up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start2 Jun 2017
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Why it stopped: Trial futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Surgical Associates
- Responsible party
- Sponsor
- Investigators
- Yaron Shargall, MD FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547168
- Sponsor's protocol ID
- SJHH_Lung_AF
- Acronym
- Lung-AF
- Status last verified
- Feb 2021
- First submitted
- 1 Sep 2015
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection
- ClinicalTrials.gov ID
- NCT02547168
- Acronym / sponsor ID
- Lung-AF / SJHH_Lung_AF
- Conditions
- Lung Cancer, Atrial Fibrillation, Stroke
- Keywords
- Atrial Fibrillation, Symptomatic Atrial Fibrillation, Asymptomatic Atrial Fibrillation, Lung Resection, Ambulatory Cardiac Monitor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial futility
- Enrolment
- 27 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Surgical Associates
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iRhythm ZIO XT patch group | Experimental | Device: iRhythm ZIO XT patchThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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 known adhesive allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iRhythm ZIO XT patchThe 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. | Device | iRhythm ZIO XT patch group |
Primary outcome
Monthly rate of patient accrual
Time frame: Ongoing from date of study initiation through to sample size completion, estimated to be 12 months
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
Time frame: 28 day time period around lung resection
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
Time frame: 28 day time period around lung resection
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
Time frame: 28 day time period around lung resection
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.
9 secondary outcomes
Baseline incidence of asymptomatic atrial fibrillation before lung resection
Time frame: Measured from 2 weeks preceding lung resection up to the day of procedure
The number of post-operative atrial fibrillation events
Time frame: 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
Time frame: 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
Time frame: Comparison of the two intervals of 14 days preceding and 14 days following lung resection
Rate of other non- atrial fibrillation arrhythmia
Time frame: Measured from post-operative day 1 to 14 days following lung resection
Impact of resection intensity (larger versus smaller resection size) on the development of any atrial fibrillation events
Time frame: Measured from post-operative day 1 to 14 days following lung resection
Impact of use of minimally invasive surgery on the development of any atrial fibrillation events
Time frame: Measured from post-operative day 1 to 14 days following lung resection
Measurement of the difference of 90 day mortality in event-free patients and those with atrial fibrillation
Time frame: Interval from the date of surgery to up to 90 days after surgery
Measurement of the difference of rates of stroke in event-free patients and those with atrial fibrillation
Time frame: Interval from the date of surgery to up to 90 days after surgery
Results and safety
The study was stopped early (reason given: Trial futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Shargall, MD FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iRhythm ZIO XT patch in people with Lung Cancer and Atrial Fibrillation, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Trial futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly rate of patient accrual (time frame: Ongoing from date of study initiation through to sample size completion, estimated to be 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.