Atrial FibrillationLEARN-AFNCT04290559
Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
An observational study of Atrial Fibrillation, run by Newmarket Electrophysiology Research Group Inc at 1 site in Canada.
Trial summary
The primary objective of this study is to determine the atrial fibrillation burden reduction, or absolute atrial fibrillation burden, associated with improvement in quality of life in patients undergoing ablation of persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Reveal LINQ ILR implant before AF ablation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2018to Sep 2022
- Phase
- Observational
- 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
Study population: Patients with persistent or long-standing persistent atrial fibrillation and an AF burden of equal or more than 80%, referred for an atrial fibrillation catheter ablation.
Who may be able to join
- Age > 18 years
- Patients undergoing first-time or redo AF ablation.
- Persistent or long-standing persistent AF
- Symptomatic atrial fibrillation
- Willing and able to provide informed consent.
- Willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored
- Atrial fibrillation burden equal or more than 80% prior to the ablation
Who cannot join
- Paroxysmal AF
- If the patient has had a cardioversion within 2 months of the ablation
- Patients with contraindication to oral or intravenous anticoagulation.
- Contraindication to implantation of an ILR
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Southlake Regional Health Centre
Newmarket, Ontario, L3Y2P9
Sherri Patterson, BScN, 905-895-4521 ext. 2149, SPatterson@southlakeregional.org
About this study
Official title: Long-term Monitoring After Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
The primary objective of this study is to determine the atrial fibrillation burden reduction, or absolute atrial fibrillation burden, associated with improvement in quality of life in patients undergoing ablation of persistent atrial fibrillation.
Read the detailed description
Atrial fibrillation (AF) is associated with a higher risk of stroke, heart failure and deterioration in patients' quality of life and it also has great effect on health care resource utilization due to increasing morbidity and mortality. Catheter ablation has shown to improve patients' quality of life (QOL), even in those who undergo a repeat procedure, equalizing healthy population and lowering subsequent health care resource utilization.
Success rates are usually based on an endpoint of total elimination of AF, typically absence of any AF recurrence >30 seconds. While this is a high standard for clinical trial reporting, it does not necessarily measure the "clinical" success, since many patients will experience significant reduction in their AF burden with accompanying improvement in their functional status despite having ongoing brief recurrences of AF.
This is a prospective non-randomized, single-arm, cohort study. 200 patients with persistent atrial fibrillation undergoing catheter ablation will be enroled. AF burden post procedure will be evaluated with continuous monitoring with an implantable loop recorder (ILR) to assess recurrences and AF burden. QOL will be measured using the CCS-SAF severity scale, SF-36 and AFEQT scales pre-ablation and at 12 and 24 months.
- Conditions
- Atrial Fibrillation
- Being tested
- Reveal LINQ ILR implant before AF ablation
- Keywords
- Catheter ablation, Quality of life, Atrial fibrillation burden, Persistent atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQ ILR implant before AF ablationProcedure or surgery
Patients will undergo insertion of a LINQ ILR before the atrial fibrillation ablation performed according to standard clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
AF burden correlated with change in QOL.
AF burden change and absolute AF burden correlated with change in QOL mesured at 12 and 24 months after the AF ablation
Measured: 12 months, 24 months
Secondary outcomes (4)
Freedom of atrial arrhythmia
Freedom of atrial tachycardia/atrial flutter/atrial fibrillation (> 30 sec) at 12 and 24 months after the ablation
Measured: 12 months, 24 months
Economic evaluation
Change in AF burden correlated with change of health care resource utilization
Measured: 12 months, 24 months
Incidence of silent AF recurrences
Total asymptomatic AF burden (Percent time in AF)
Measured: 12 months, 24 months
Impact of antiarrhythmic treatment
Compare quality of life on and off antiarrhythmic medications using 36-Item Short Form Survey (SF-36) scale: range 0-100, 100 is best.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start10 Sep 2018
- Primary completionSep 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newmarket Electrophysiology Research Group Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290559
- Sponsor's protocol ID
- NERG-04
- Acronym
- LEARN-AF
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Monitoring After Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
- ClinicalTrials.gov ID
- NCT04290559
- Acronym / sponsor ID
- LEARN-AF / NERG-04
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation, Quality of life, Atrial fibrillation burden, Persistent atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Newmarket Electrophysiology Research Group IncUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 2 Mar 2020 (actual)
- 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.
The primary objective of this study is to determine the atrial fibrillation burden reduction, or absolute atrial fibrillation burden, associated with improvement in quality of life in patients undergoing ablation of persistent atrial fibrillation.
Detailed description
Atrial fibrillation (AF) is associated with a higher risk of stroke, heart failure and deterioration in patients' quality of life and it also has great effect on health care resource utilization due to increasing morbidity and mortality. Catheter ablation has shown to improve patients' quality of life (QOL), even in those who undergo a repeat procedure, equalizing healthy population and lowering subsequent health care resource utilization.
Success rates are usually based on an endpoint of total elimination of AF, typically absence of any AF recurrence >30 seconds. While this is a high standard for clinical trial reporting, it does not necessarily measure the "clinical" success, since many patients will experience significant reduction in their AF burden with accompanying improvement in their functional status despite having ongoing brief recurrences of AF.
This is a prospective non-randomized, single-arm, cohort study. 200 patients with persistent atrial fibrillation undergoing catheter ablation will be enroled. AF burden post procedure will be evaluated with continuous monitoring with an implantable loop recorder (ILR) to assess recurrences and AF burden. QOL will be measured using the CCS-SAF severity scale, SF-36 and AFEQT scales pre-ablation and at 12 and 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent or long-standing persistent atrial fibrillation and an AF burden of equal or more than 80%, referred for an atrial fibrillation catheter ablation.
Key inclusion criteria (7 listed)
- Age > 18 years
- Patients undergoing first-time or redo AF ablation.
- Persistent or long-standing persistent AF
- Symptomatic atrial fibrillation
- Willing and able to provide informed consent.
Key exclusion criteria (4 listed)
- Paroxysmal AF
- If the patient has had a cardioversion within 2 months of the ablation
- Patients with contraindication to oral or intravenous anticoagulation.
- Contraindication to implantation of an ILR
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 |
|---|---|---|
| Reveal LINQ ILR implant before AF ablationPatients will undergo insertion of a LINQ ILR before the atrial fibrillation ablation performed according to standard clinical practice. | Procedure or surgery | – |
Primary outcome
AF burden correlated with change in QOL.
Time frame: 12 months, 24 months
AF burden change and absolute AF burden correlated with change in QOL mesured at 12 and 24 months after the AF ablation
4 secondary outcomes
Freedom of atrial arrhythmia
Time frame: 12 months, 24 months
Economic evaluation
Time frame: 12 months, 24 months
Incidence of silent AF recurrences
Time frame: 12 months, 24 months
Impact of antiarrhythmic treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Newmarket Electrophysiology Research Group Inc 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherri Patterson, BScN (905-895-4521 ext. 2149, SPatterson@southlakeregional.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF burden correlated with change in QOL. (time frame: 12 months, 24 months). 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 31 Mar 2020.