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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with persistent or paroxysmal AF requiring catheter ablation and meet the inclusion/exclusion criteria for RASTA-AF, but decline or are not approached for participation in the Randomized Clinical Trial will be asked to participate in RASTA Cohort.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
198 Participants
are grouped into 1 trial groupGroup A: RASTA AF Cohort
Trial outcomes
Primary outcomes
1
Number of patients with atrial fibrillation (AF) related hospitalizations
Defined as any hospitalization (greater than 24 hours) from 2 months post ablation to end of follow up due to: atrial fibrillation/atrial flutter, stroke/transient ischemic attack/systemic embolism, heart failure, syncope or bradycardia requiring pacing.
Time frame
Up to 60 months2
Number of patients with atrial fibrillation (AF) related ED visits
Defined as any presentation to the emergency department (less than 24 hours) due to: atrial fibrillation/atrial flutter, stroke/transient ischemic attack/systemic embolism, heart failure, syncope or bradycardia requiring pacing.
Time frame
Up to 60 months3
Number of patients with clinically significant atrial fibrillation post ablation
Clinically significant AF events lasting greater or equal to 24 hours within 26 hours (either an irregular R-R interval or atrial cycle length less than 280 ms, as obtained from an insertable cardiac monitor) from 2 months post ablation to end of follow-up.
Time frame
Up to 60 monthsSecondary outcomes
1
Number of patients with a composite of AF-related hospitalizations and ED visits or clinically significant AF
Defined as any hospitalization or presentation to the emergency department due to: atrial fibrillation/atrial flutter, stroke/transient ischemic attack/systemic embolism, heart failure, syncope or bradycardia requiring pacing and/or clinically significant atrial fibrillation (greater than or equal to 24 hours with symptoms) from randomization to end of follow up.
Time frame
Up to 60 months2
Number of patients with stroke or systemic embolism
Hospitalization or treatment for a stroke or systemic embolism
Time frame
Up to 60 months3
Quality of Life - CCS SAF scale
Symptom burden as measured by the Canadian Cardiovascular Society (CCS) Severity of Atrial Fibrillation (SAF) Scale. CCS-SAF scores range from 0 to 4, with higher values representing more severe impact of AF-related symptoms on quality of life and activities of daily living.
Time frame
Up to 60 months4
Quality of Life - AFEQT
Quality of life scale as measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) scale. The scale consists of 21 questions with 7-point Likert scale responses. Questions 1-18 are grouped into three subscales (symptoms, daily activities and treatment concern). Questions 19-21 capture satisfaction with treatment and are not included in the HRQoL score of the questionnaire. Overall and subscale scores range from 0 to 100. Lower cores correspond to higher levels of disability (e.g., 0 corresponds to complete disability or responding "extremely" limited, difficult or bothersome to all questions answered), withe a score of 100 corresponds to no disability (e.g., responding "not at all" limited, difficult or bothersome to all questions answered). For Satisfaction questions, a score of 100 corresponds to extreme satisfaction with current treatment.
Time frame
Up to 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ratika Parkash
Lead sponsor
Nova Scotia Health Authority
Sponsor institution
Nova Scotia Health Research Fund
Collaborator
Source ClinicalTrials.gov