Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life (LEARN-AF)

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Reveal LINQ ILR implant before AF ablation

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sherri Patterson, BScN; Phone Number: 2149 905-895-4521; Email: SPatterson@southlakeregional.org

Study Locations

• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y2P9
      • Recruiting
      • Southlake Regional Health Centre
      • Contact: Sherri Patterson, BScN; Phone Number: 2149 905-895-4521; Email: SPatterson@southlakeregional.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Newmarket Electrophysiology Research Group Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 29, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Atrial fibrillation burden; Catheter ablation; Persistent atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NERG-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No