Clinical trial NCT06249269: Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study
Official title: Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation, Paroxysmal or Persistent
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Research Fund
First posted: 2024-02-08
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Randomized clinical trials remain the gold standard for determining the efficacy of an intervention, however, it is well known that patients will decline participation in clinical trials for various reasons. It is critical to understand outcomes of patients who are eligible for a clinical trial, but decline participation, as it may affect the magnitude of an intervention, and ultimately its clinical meaningfulness. The RASTA cohort study will address this issue in patients with AF. Atrial fibrillation has become a significant burden globally, and is more often present in older individuals. This is particularly important in Nova Scotia where our healthcare system is especially burdened as the population ages, 20% of the current population is \>65 years. Improved understanding of the AF patient population in Nova Scotia, and beyond, will permit further understanding of how best to treat this increasingly common chronic illness.

The RASTA-Cohort study is designed to answer the following questions:

1. Do 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.
2. Do patients who do not participate in the RASTA AF RCT suffer from worse AF-related outcomes than patients in the study, as compared to the control arm and intervention arm.

This is a multicenter, prospective cohort study that will enrol patients who are eligible for, but do not participate in the RASTA-AF study, but agree to be followed in this registry. Once the patient has consented to participate in RASTA Cohort, they will be scheduled for their AF ablation at the next available timeframe (2-4 months from entry into the study). All patients will continue to receive care as per current guidelines; this will be managed at the discretion of their treating physician.

Clinical characteristics collected at baseline include quality of life (CCS-SAF, AFEQT, EQ-5D), physical activity measures: IPAQ and stress test results (where available), blood pressure, weight, hemoglobin A1C, alcohol use and smoking cessation. The measures of risk factors will be performed in a similar fashion as the main study to ensure that these can be compared.

The conservative estimated event rate for the cohort is 20% greater than that of the control population of the RASTA AF study. Given the control population having an event rate of 30%, and the cohort group being 43.5%, a sample size of 313 patients is required in the control population of RASTA and 185 patients in the cohort group with a minimum 2 year follow up. Using a 7% loss to follow up rate, the sample size required in the cohort group is 198 patients. This sample size will provide 90% power with a type I error of 0.05 to detect a difference in survival between the cohort and the control group in the study. There is \>99% power to detect a difference between the intervention group and the cohort group based on the sample of 198 patients.

Eligibility criteria: Inclusion Criteria:

* 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 participation in the RASTA AF clinical trial.

Exclusion Criteria:

* permanent AF (AF lasting \> 3 years),
* prior catheter ablation for AF
* left atrial size \> 5.5 cm,
* New York Heart Association Class IV heart failure
* participation in a cardiac rehabilitation program within the last year,
* currently performing exercise training \>150 minutes/week of moderate to vigorous physical activity,
* unable to exercise,
* unable to give informed consent,
* other noncardiovascular medical condition making 1 year survival unlikely

Primary outcomes:
measure: Number of patients with atrial fibrillation (AF) related hospitalizations
timeFrame: Up to 48 months
measure: Number of patients with atrial fibrillation (AF) related ED visits
timeFrame: Up to 48 months
measure: Number of patients with clinically significant atrial fibrillation post ablation
timeFrame: Up to 48 months
Secondary outcomes:
measure: Number of patients with a composite of AF-related hospitalizations and ED visits or clinically significant AF
timeFrame: Up to 48 months
measure: Number of patients with stroke or systemic embolism
timeFrame: Up to 48 months
measure: Quality of Life - CCS SAF scale
timeFrame: Up to 24 months
measure: Quality of Life - AFEQT
timeFrame: Up to 24 months
measure: Quality of Life Health Outcomes using EuroQol-5D-5L
timeFrame: Up to 24 months
measure: Number of patients with gender association, Atrial fibrillation risk factors and risk factor management
timeFrame: Up to 24 months
measure: Number of patients with recurrent AF Catheter ablations
timeFrame: Up to 48 months
measure: Number of patients with recurrent cardioversions for atrial fibrillation
timeFrame: Up to 48 months
measure: Number of patients with Major bleeding
timeFrame: Up to 48 months
measure: Number of Deaths
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEIIHSC
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health
name: Ratika Parkash, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: