The RASTA-AF Clinical Trial
A combined strategy of risk factor management and catheter ablation for patients with symptomatic atrial fibrillation
Background:
Atrial Fibrillation (AF) is a common heart arrhythmia which causes the heart to beat in an irregular and sometimes rapid fashion. Symptoms can include general fatigue and fatigue when exercising, dizziness, shortness of breath and anxiety. These symptoms can be severe and lead to poor quality of life and high healthcare utilization. AF can be treated with medications that aim to treat either the hearts rate, or rhythm. When medications aren’t successful in treating symptoms then a hospital-procedure called catheter ablation can be done to help prevent the electrical signals that trigger the heart to beat irregularly. Many people see improvements in their quality of life after ablation, but, despite advances in cather ablation techniques, the recurrence of AF remains high. If it returns, a repeat procedure and/or heart medication(s) may be required.
Objective:
To determine if symptomatic patients can benefit from a combined strategy of aggressive risk factor modification and catheter ablation.
Standard care for AF patients includes assessment and usual interventions for risk factors, such as sleep apnea, high Body Mass Index (BMI), hypertension, heart failure, diabetes, smoking and excessive alcohol use. However, there is currently no consistency as to when these risk factors are addressed. It is primarily the level of aggression and timelines for risk factor management (ie., prior to ablation) that is experimental in this study, with the exception of a home-based cardiac rehabilitation program, which is a not standardly offered to AF patients referred for ablation.
Patients will be randomized to one of two study arms. The control arm will receive standard care from their health care providers, including catheter ablation. The intervention arm will receive personalized aggressive risk factor modification including a one-on-one home-based exercise and nutrition program.
The primary outcome to be compared between the two groups is a composite of AF-related hospitalizations, Emergency Department (ED) visits, episode of AF lasting 24 or more hours, and death. Secondary outcomes will include AF burden.
RASTA-AF is registered with ClinicalTrials.gov – NCT03186976
Study Type:
Intervention – Risk Factor Modification
Study Design
Multicenter, prospective, parallel group, randomized clinical trial
No. of Sites
16
No. of Participants
670
Study Period
2019-2024
Primary Outcome
Composite of AF-related hospitalizations, ED visits, episode of AF lasting ≥ 24 hours, and death
Secondary Outcomes
Individual components of the primary outcome, AF burden, quality of life
Sponsors
Abbott
CIHR
Principal Investigator
Dr. Ratika Parkash
Dalhousie University and Nova Scotia
Co-Investigators
Dr. John Sapp, Dalhousie University and Nova Scotia Health
Dr. Allan Skanes, London Health Sciences Center
Dr. David Birnie, Ottawa Heart Institute
Dr. Chris Blanchard, Dalhousie University
Dr. Jennifer Reed, Ottawa Heart institute
Dr. Paul Dorian, University of Toronto
Dr. Anthony Tang, University of Western Ontario and London Health Sciences Centre
Dr. Robert Reid, Ottawa Heart Institute
Dr. Stephen Wilton, University of Calgary and Libin Cardiovascular Institute
Dr. Nick Giacomantonio, Dalhousie University and Nova Scotia Health
Dr. George Wells, Ottawa Cardiovascular Research Methods Center
Contact Us
Study Office rastaaf@nshealth.ca
Project Manager: Laura Hamilton
Data Management: Aileen Davis
Home-based Cardiac Rehabilitation
English Core Lab – Matheus Mistura
French Core Lab – Jérémy Hupé
Our Partners
RASTA-AF 