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Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation (COAST-AF)

COAST-AF

Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation

Lead PI & Sponsor

Dr. Pablo Nery, Ottawa Heart Institute Research Corporation

Local PI

Dr. Allan Skanes

Research Staff

Keza Motlana

Objective

The primary objective of this study is to assess the efficacy of a patient-tailored ablation strategy guided by atrial scar mapping in addition to PVI when compared to PVI alone in subjects with PeAF. The secondary objective is to evaluate safety outcomes in patients undergoing AF ablation.

Target Number of Patients

40

Currently Enrolled

14

Primary Outcomes

  • AF rate of documented (>30 seconds) of atrial arrhythmias occurring from day 91 to 18 months post ablation

Secondary Outcomes

  • A composite safety endpoints - procedure related complications (stroke, PV stenosis, pericarditis, cardiac perforation, major bleeding) and/or death.
  • AF burden assessment at 12 and 18 months
  • Need for repeat ablation procedure for AF, AFl or AT
  • Need for emergency room visits or hospitalization
  • Assessment of the relationship between AAF burden, symptoms and quality of life
  • Time to first recurrence at 18 months according to sex and atrial LVA extent
  • Total ablation delivery time / total procedure duration
  • Quality of life and health economic analyses

Inclusion Criteria

  • Age ≥18 years
  • Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF
  • Persistent AF defined as a sustained episode beyond 3 months in duration
  • At least one episode of AF must have been documented on 12-lead ECG, Holter monitor, loop monitor or trans-telephonic monitor (TTM) within 36 months of enrollment in the study
  • Modified DR-FLASH47 score ≥ 3
  • Subjects must be able to provide informed consent

Exclusion Criteria

  • History of previous catheter ablation for AF or left atrial flutter
  • History of previous surgical ablation for AF
  • Known intracardiac thrombus
  • Contraindication to systemic oral anticoagulation therapy
  • Reversible causes of AF
  • Hypertrophic cardiomyopathy
  • Severe valvular disease
  • Patients that are pregnant or breastfeeding
  • Comorbid condition with life expectancy <1 year

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice and is associated with an increased risk of stroke, heart failure and death. One strategy to treatment AF is Catheter Ablation (CA). The optimal CA strategy for persistent AF remains unknown. Current data highlights the need for a better understanding of the substrate and mechanisms of arrhythmia maintenance in this population. Atrial scar-based catheter ablation has recently emerged as a promising strategy for ablation of AF. The Investigators hypothesize that catheter ablation of persistent AF (PeAF) tailored to abolish abnormal atrial substrate identified by intracardiac atrial scar mapping in addition to pulmonary vein isolation (PVI) will result in higher procedural success rates when compared to PVI alone.

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