Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study

NCT06249269 | Recruiting

• 1 other identifier: RP-08
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 7

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.

Conditions

Atrial Fibrillation, Paroxysmal or Persistent

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 60 months

• 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.

  Up to 60 months

• 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.

  Up to 60 months

Secondary Outcomes (10)

• Number of patients with a composite of AF-related hospitalizations and ED visits or clinically significant AF

  Up to 60 months

• Number of patients with stroke or systemic embolism

  Up to 60 months

• Quality of Life - CCS SAF scale

  Up to 60 months

• Quality of Life - AFEQT

  Up to 60 months

• Quality of Life Health Outcomes using EuroQol-5D-5L

  Up to 24 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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,
• 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
• less than 18 years of age

Sponsors & Collaborators

• Ratika Parkash: lead
• Nova Scotia Health Research Fund: collaborator

Study Sites (7)

Foothills Hospital

Calgary, Alberta, Canada

RECRUITING

QEIIHSC

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

RECRUITING

Sunnybrook Hospital

Toronto, Ontario, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

RECRUITING

Regina General Hospital

Regina, Saskatchewan, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ratika Parkash, MD, FRCPC

  Nova Scotia Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Hamilton, BSC, MAHSR

CONTACT

902 473-7226; laura.hamilton@nshealth.ca

Karen Giddens

CONTACT

902 237-5551; karen.giddens@nshealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: February 8, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)