An observational study in Atrial Fibrillation, Paroxysmal or Persistent, sponsored by Ratika Parkash. Recruiting at 7 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Ratika Parkash · Observational
Among 318 studies in Atrial Fibrillation with a site in Canada — 50 open to participants now, 73 under way, 8 of them phase 3. Atrial Fibrillation · Canada.
Among the 318 studies in Atrial Fibrillation with a site in Canada, this one is the 41st largest by planned enrollment of the 57 observational ones that give a count, is one of 20 that started in 2024, is one of 57 observational ones, reaches primary completion later than 22 of the 72 other live ones, and was the 285th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →50 of the 318 studies in Atrial Fibrillation with a site in Canada are open now. Recruiting first, the newest first:
Milestone Pharmaceuticals Inc. · Sites in Canada, United States, Netherlands
Ages 18+
Regeneron Pharmaceuticals · Sites in Canada, United States, Japan
Ages 18+
Pavel Antiperovitch · Sites in Canada
Ages 18+
French Cardiology Society · Sites in Canada, France, New Zealand
Ages 18+
Ottawa Hospital Research Institute · Sites in Canada
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
318 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 29 · Phase 3 64 · Phase 4 30
First in 1999; this study’s year is marked. 20 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 198 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Median enrollment 282 across the 261 interventional studies, 297 across the 57 observational. Of the 217 that completed or were terminated, 80 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
128 of 318 have an industry lead sponsor. The 10 most frequent:
Ratika Parkash is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Ratika Parkash has 1 study filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
23 of the studies in Atrial Fibrillation with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT02150902Ottawa Heart Institute Research CorporationAugmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence | 2026-11-27 |
| NCT07245147Jacqueline JozaREDO-AF: Randomized Evaluation of Dual Options for AF Re-intervention | 2026-12 |
| NCT06249269Ratika ParkashReversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study | 2026-12 |
| NCT05600829University of CalgaryA Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity | 2026-12-30 |
Add all 23 to your calendar (.ics) → With an account.
Among the 318 studies in Atrial Fibrillation with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 60 months
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.
Time frame: Up to 60 months
Number of patients with stroke or systemic embolism
Hospitalization or treatment for a stroke or systemic embolism
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months
Number of patients with gender association, Atrial fibrillation risk factors and risk factor management
GENESIS PRAXY Gender Questionnaire
Time frame: Up to 24 months
Number of patients with recurrent AF Catheter ablations
Any subsequent catheter ablations after the initial procedure
Time frame: Up to 60 months
Number of patients with recurrent cardioversions for atrial fibrillation
Electrical or chemical cardioversions
Time frame: 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
Time frame: Up to 60 months
Number of Deaths
Study Exit due to death from time of inclusion
Time frame: Up to 60 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 31 months is below that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Ratika Parkash