Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study

Status: Recruiting
Location: See all (7) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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).

Locations
Other Locations
Canada
Foothills Hospital
RECRUITING
Calgary
QEIIHSC
RECRUITING
Halifax
London Health Sciences Centre
RECRUITING
London
Montreal Heart Institute
RECRUITING
Montreal
University of Ottawa Heart Institute
RECRUITING
Ottawa
Regina General Hospital
RECRUITING
Regina
Sunnybrook Hospital
RECRUITING
Toronto
Contact Information
Primary
Laura Hamilton, BSC, MAHSR
laura.hamilton@nshealth.ca
902 473-7226
Backup
Karen Giddens
karen.giddens@nshealth.ca
902 237-5551
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-03
Participants
Target number of participants: 198
Treatments
RASTA AF Cohort
Patients who meet the inclusion criteria for RASTA-AF, and do not meet any of the exclusion criteria but decline or are not approached for participation in the RCT will be asked to participate.
Related Therapeutic Areas
Sponsors
Leads: Ratika Parkash
Collaborators: Nova Scotia Health Research Fund

This content was sourced from clinicaltrials.gov