Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study

Status: Recruiting
Location: See location...
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 participation in the RASTA AF clinical trial.

Locations
Other Locations
Canada
QEIIHSC
RECRUITING
Halifax
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