Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life

• Conditions: Atrial Fibrillation

• Registration Number: NCT04290559
• Lead Sponsor: Newmarket Electrophysiology Research Group Inc

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.

Study Timeline

• Study Start: 2018-09-10
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-26
• Status Verified: 2020-03
• Study First Posted: 2020-03-02
• Last Update Submitted: 2020-03-29
• Last Update Posted: 2020-03-31
• Primary Completion: 2021-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AF burden correlated with change in QOL.	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

Secondary Outcome Measures

Name	Time	Method
Freedom of atrial arrhythmia	12 months, 24 months	Freedom of atrial tachycardia/atrial flutter/atrial fibrillation (\> 30 sec) at 12 and 24 months after the ablation
Incidence of silent AF recurrences	12 months, 24 months	Total asymptomatic AF burden (Percent time in AF)
Economic evaluation	12 months, 24 months	Change in AF burden correlated with change of health care resource utilization
Impact of antiarrhythmic treatment	12 months	Compare quality of life on and off antiarrhythmic medications using 36-Item Short Form Survey (SF-36) scale: range 0-100, 100 is best.

Trial Locations

Locations (1)

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada