NCT06249269|Recruiting
Reversal of Atrial Substrate to Prevent Atrial Fibrillation Cohort Study
RASTA-Cohort
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RASTA-Cohort
Sponsor study identifier
observational
198
1 country
7
Study Start
May 1, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 3, 2024
Actual (reported)February 8, 2024
Actual (reported)May 1, 2024
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
Foothills Hospital
Calgary, Alberta, Canada
QEIIHSC
Halifax, Nova Scotia, B3H 3A7, Canada
Ratika Parkash, MD, FRCPC
Nova Scotia Health
First Submitted
January 3, 2024
First Posted
February 8, 2024
Study Start
May 1, 2024
Actual (reported)Primary Completion
December 2026
EstimatedRESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
Contact the study team to confirm eligibility.
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 2, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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