Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life

Atrial Fibrillation Clinical Trial

— LEARN-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04290559
• Other study ID #: NERG-04
• Status: Recruiting
• Start date: September 10, 2018
• Est. completion date: September 2022

Study information

• Verified date: March 2020
• Source: Newmarket Electrophysiology Research Group Inc
• Contact: Sherri Patterson, BScN
• Phone: 905-895-4521
• Email: SPatterson[@]southlakeregional.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Newmarket Electrophysiology Research Group Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Economic evaluation	Change in AF burden correlated with change of health care resource utilization	12 months, 24 months
Secondary	Incidence of silent AF recurrences	Total asymptomatic AF burden (Percent time in AF)	12 months, 24 months
Secondary	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