Clinical trial NCT04290559: Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
Official title: Long-term Monitoring After Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Catheter ablation
Quality of life
Atrial fibrillation burden
Persistent atrial fibrillation
Lead sponsor: Newmarket Electrophysiology Research Group Inc
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: AF burden correlated with change in QOL.
timeFrame: 12 months, 24 months
Secondary outcomes:
measure: Freedom of atrial arrhythmia
timeFrame: 12 months, 24 months
measure: Economic evaluation
timeFrame: 12 months, 24 months
measure: Incidence of silent AF recurrences
timeFrame: 12 months, 24 months
measure: Impact of antiarrhythmic treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
References: