Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Newmarket Electrophysiology Research Group Inc
Updated on 19 February 2024
persistent atrial fibrillation
fibrillation

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.

Details
Condition Arrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation
Age 18years - 100years
Treatment Reveal LINQ ILR implant before AF ablation
Clinical Study IdentifierNCT04290559
SponsorNewmarket Electrophysiology Research Group Inc
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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