Recruiting

Atrial Fibrillation

Sponsor:

Ratika Parkash

Code:

NCT06249269

Conditions

Atrial Fibrillation, Paroxysmal or Persistent

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06249269

Start date

May 1, 2024

Status verified date

Nov, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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).

Exclusion Criteria:

  • 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

Study Design

Enrollment

198 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of patients with atrial fibrillation (AF) related hospitalizations [ Time Frame: Up to 60 months ]
  • Number of patients with atrial fibrillation (AF) related ED visits [ Time Frame: Up to 60 months ]
  • Number of patients with clinically significant atrial fibrillation post ablation [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

Laura Hamilton, BSC, MAHSR

902 473-7226laura.hamilton@nshealth.ca

Karen Giddens

902 237-5551karen.giddens@nshealth.ca

Locations

Foothills Hospital

Recruiting

Calgary, Alberta, Canada

Principal Investigator:

Stephen Wilton, MD, FRCPC

QEIIHSC

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

Laura Hamilton

902-473-7226laura.hamiton@nshealth.ca

Principal Investigator:

Ratika Parkash, MD, FRCPC

London Health Sciences Centre

Recruiting

London, Ontario, Canada

Principal Investigator:

Allan Skanes, MD, FRCP(C)

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada

Principal Investigator:

David Birnie, MD, FRCP(C)

Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Eugene Crystal, MD, FRCP(C)

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada

Principal Investigator:

Lena Rivard, MD, FRCP (C)

Regina General Hospital

Recruiting

Regina, Saskatchewan, Canada

Principal Investigator:

Omar Sultan, MD, FRCP(C)

More Information

Sponsor

Ratika Parkash

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ratika Parkash on 2025-12-02.