Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRatika Parkash

About this trial

Atrial fibrillation (AF) is a major health problem, with a prevalence of 0.4-1% of the population. It results in high healthcare costs and significant morbidity, especially for patients with severe symptoms. The RASTA-AF randomized control trial (RCT) is designed to answer the following question: does vigorous treatment of AF with aggressive risk factor management plus catheter ablation reduce AF-related outcomes as compared to catheter ablation plus usual care in patients with symptomatic AF and risk factors that promote AF.

This study is a multicenter, prospective cohort study that will enrol patients who decline participation in the RASTA-AF RCT but agree to be followed in a registry. The objective of RASTA-Cohort is to determine whether patients who decline participation in the RASTA-AF RCT have different clinical characteristics and quality of life than patients who accept participation in the study, and whether they suffer from worse AF-related outcomes than patients in the RCT.

Eligibility criteria

Qualifiers

symptomatic AF (CCS-SAF ≥2),

paroxysmal or persistent atrial fibrillation despite rate control, desiring catheter ablation and either: i) BMI ≥ 30 or, ii) at least two of the following: BMI>27, BP>140/90 mmHg or history of hypertension, Diabetes, Heart failure (prior heart failure admission or LVEF<40%), Age ≥ 65 years, Prior stroke/TIA, Current smoker, Excessive alcohol use {For women: 10 or more drinks/week, more than 2 drinks a day (most days). For men: 15 or more drinks/week, more than 3 drinks a day (most days)}, and iii) declined or were not approached for participation in the main study. Eligible patients must have received catheter ablation for AF during the same timeline of the RASTA-AF Mian Study (November 1st, 2019 to December 31st, 2025).

Disqualifiers

permanent AF (AF lasting > 3 years),

prior catheter ablation for AF

New York Heart Association Class IV heart failure

participation in a cardiac rehabilitation program within the last year,

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

198 Participants
are grouped into 1 trial group

Locations

7
Foothills Hospital CalgaryAlberta, Canada
QEIIHSCB3H 3A7, HalifaxNova Scotia, Canada
London Health Sciences Centre LondonOntario, Canada
University of Ottawa Heart Institute OttawaOntario, Canada

Sponsors and collaborators

Ratika Parkash

Lead sponsor

Nova Scotia Health Authority

Sponsor institution

Nova Scotia Health Research Fund

Collaborator