Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
NCT ID: NCT04290559
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2018-09-10
2022-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Reveal LINQ ILR implant before AF ablation
Patients will undergo insertion of a LINQ ILR before the atrial fibrillation ablation performed according to standard clinical practice.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Newmarket Electrophysiology Research Group Inc
OTHER
Responsible Party
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Locations
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Southlake Regional Health Centre
Newmarket, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Sherri Patterson, BScN
Role: primary
Other Identifiers
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NERG-04
Identifier Type: -
Identifier Source: org_study_id