Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Monitoring After Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Reveal LINQ ILR implant before AF ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of atrial arrhythmia | Freedom of atrial tachycardia/atrial flutter/atrial fibrillation (> 30 sec) at 12 and 24 months after the ablation | 12 months, 24 months | 
| Economic evaluation | Change in AF burden correlated with change of health care resource utilization | 12 months, 24 months | 
| Incidence of silent AF recurrences | Total asymptomatic AF burden (Percent time in AF) | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter ablation, Quality of life, Atrial fibrillation burden, Persistent atrial fibrillation