Atrial Fibrillation, Paroxysmal or PersistentRASTA-CohortNCT06249269
Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study
An observational study of Atrial Fibrillation, Paroxysmal or Persistent, run by Ratika Parkash at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal or Persistent
- How many people
- 198 participants
- Where
- 7 sitesCanada
- Study dates
- 1 May 2024to Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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,
Show all 9Show fewer
- unable to give informed consent,
- other noncardiovascular medical condition making 1 year survival unlikely
- less than 18 years of age
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Recruiting
Foothills Hospital
Calgary, Alberta
Jennifer McKeage
Stephen Wilton, MD, FRCPC
- Recruiting
QEIIHSC
Halifax, Nova Scotia, B3H 3A7
Laura Hamilton, 902-473-7226, laura.hamiton@nshealth.ca
Ratika Parkash, MD, FRCPC
- Recruiting
London Health Sciences Centre
London, Ontario
Keza Motlana
Allan Skanes, MD, FRCP(C)
- Recruiting
Montreal Heart Institute
Montreal, Quebec
Caroline Girard
Lena Rivard, MD, FRCP (C)
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
Tammy Knight
David Birnie, MD, FRCP(C)
- Recruiting
Regina General Hospital
Regina, Saskatchewan
Maria Gagarinova
Omar Sultan, MD, FRCP(C)
- Recruiting
Sunnybrook Hospital
Toronto, Ontario
Ambreen Syeda
Eugene Crystal, MD, FRCP(C)
About this study
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.
Read the 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:
- 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.
- 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.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 60 months
Secondary outcomes (10)
Number of patients with a composite of AF-related hospitalizations and ED visits or clinically significant AF
Defined as any hospitalization or presentation to the emergency department due to: atrial fibrillation/atrial flutter, stroke/transient ischemic attack/systemic embolism, heart failure, syncope or bradycardia requiring pacing and/or clinically significant atrial fibrillation (greater than or equal to 24 hours with symptoms) from randomization to end of follow up.
Measured: Up to 60 months
Number of patients with stroke or systemic embolism
Hospitalization or treatment for a stroke or systemic embolism
Measured: Up to 60 months
Quality of Life - CCS SAF scale
Symptom burden as measured by the Canadian Cardiovascular Society (CCS) Severity of Atrial Fibrillation (SAF) Scale. CCS-SAF scores range from 0 to 4, with higher values representing more severe impact of AF-related symptoms on quality of life and activities of daily living.
Measured: Up to 60 months
Quality of Life - AFEQT
Quality of life scale as measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) scale. The scale consists of 21 questions with 7-point Likert scale responses. Questions 1-18 are grouped into three subscales (symptoms, daily activities and treatment concern). Questions 19-21 capture satisfaction with treatment and are not included in the HRQoL score of the questionnaire. Overall and subscale scores range from 0 to 100. Lower cores correspond to higher levels of disability (e.g., 0 corresponds to complete disability or responding "extremely" limited, difficult or bothersome to all questions answered), withe a score of 100 corresponds to no disability (e.g., responding "not at all" limited, difficult or bothersome to all questions answered). For Satisfaction questions, a score of 100 corresponds to extreme satisfaction with current treatment.
Measured: Up to 60 months
Quality of Life Health Outcomes using EuroQol-5D-5L
The EQ-5D-5L quality of life questionnaire will be used to assess health related outcomes. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The lower the number, the better the impact on quality of life.
Measured: Up to 24 months
Number of patients with gender association, Atrial fibrillation risk factors and risk factor management
GENESIS PRAXY Gender Questionnaire
Measured: Up to 24 months
Number of patients with recurrent AF Catheter ablations
Any subsequent catheter ablations after the initial procedure
Measured: Up to 60 months
Number of patients with recurrent cardioversions for atrial fibrillation
Electrical or chemical cardioversions
Measured: Up to 60 months
Number of patients with Major bleeding
Fall in Hgb of ≥2 g/dL, transfusion of ≥2 units packed red blood cells (PRBC) or whole blood, in a critical location (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial
Measured: Up to 60 months
Number of Deaths
Study Exit due to death from time of inclusion
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 May 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, Paroxysmal or PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ratika Parkash
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Research Fund
- Responsible party
- Sponsor-investigator, Ratika Parkash, Nova Scotia Health Authority
- Investigators
- Ratika Parkash, MD, FRCPC, Principal investigator, Nova Scotia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249269
- Sponsor's protocol ID
- RP-08
- Acronym
- RASTA-Cohort
- Status last verified
- Nov 2025
- First submitted
- 3 Jan 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study
- ClinicalTrials.gov ID
- NCT06249269
- Acronym / sponsor ID
- RASTA-Cohort / RP-08
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Ratika ParkashUniversity, hospital or other
- Collaborators
- Nova Scotia Health Research Fund
- Study start
- 1 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with atrial fibrillation (AF) related hospitalizations
Time frame: Up to 60 months
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.
Number of patients with atrial fibrillation (AF) related ED visits
Time frame: Up to 60 months
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.
Number of patients with clinically significant atrial fibrillation post ablation
Time frame: Up to 60 months
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.
10 secondary outcomes
Number of patients with a composite of AF-related hospitalizations and ED visits or clinically significant AF
Time frame: Up to 60 months
Number of patients with stroke or systemic embolism
Time frame: Up to 60 months
Quality of Life - CCS SAF scale
Time frame: Up to 60 months
Quality of Life - AFEQT
Time frame: Up to 60 months
Quality of Life Health Outcomes using EuroQol-5D-5L
Time frame: Up to 24 months
Number of patients with gender association, Atrial fibrillation risk factors and risk factor management
Time frame: Up to 24 months
Number of patients with recurrent AF Catheter ablations
Time frame: Up to 60 months
Number of patients with recurrent cardioversions for atrial fibrillation
Time frame: Up to 60 months
Number of patients with Major bleeding
Time frame: Up to 60 months
Number of Deaths
Time frame: Up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ratika Parkash, MD, FRCPC principal investigator
Nova Scotia Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, Paroxysmal or Persistent, run by Ratika Parkash at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Hamilton, BSC, MAHSR (902 473-7226, laura.hamilton@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with atrial fibrillation (AF) related hospitalizations (time frame: Up to 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.