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Aggressive Risk Factor Management for Atrial Fibrillation (RASTA AF Trial)
N/A
Recruiting
Led By Ratika Parkash
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
RASTA AF Trial Summary
This trial looks at whether controlling risk factors and intervening when arrhythmias are triggered can reduce the recurrence of atrial fibrillation.
Who is the study for?
This trial is for adults with symptomatic atrial fibrillation who haven't improved with rate control and have at least two risk factors like obesity, high blood pressure, prior stroke or diabetes. They should want catheter ablation but can't be in severe heart failure, under 18, have a very large left atrium, unable to consent or exercise, already exercising a lot or have another serious illness.Check my eligibility
What is being tested?
The study compares aggressive risk factor management (like improving blood pressure and weight) plus standard care against standard care alone in preventing the return of atrial fibrillation after treatment. Participants are randomly assigned to one of these approaches.See study design
What are the potential side effects?
Potential side effects from interventions may include discomfort from lifestyle changes such as diet and exercise adjustments required for aggressive risk factor control. Standard care treatments' side effects depend on the specific procedures and medications used.
RASTA AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of AF related Emergency Department (ED) visits post ablation
Number of AF related hospitalizations post ablation
Number of clinically significant AF events post ablation
Secondary outcome measures
All-cause mortality
Cardioversions
Mean AF burden
+7 moreOther outcome measures
Exercise compliance - IPAQ
Number of ablation procedural complications [Safety]
Number of antiarrhythmic drug adverse effects [Safety]
+2 moreRASTA AF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aggressive Risk Factor ControlExperimental Treatment1 Intervention
Multifaceted risk factor management relating to BP, exercise, sleep apnea, alcohol intake and diabetes management
Group II: Standard of CareActive Control1 Intervention
All patients in the control arm will receive therapies for AF as per the existing guidelines. BP, cholesterol, diabetic management will be administered as per the available guidelines.
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
258 Previous Clinical Trials
83,184 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
290 Patients Enrolled for Atrial Fibrillation
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,452,747 Total Patients Enrolled
20 Trials studying Atrial Fibrillation
649,251 Patients Enrolled for Atrial Fibrillation
AbbottIndustry Sponsor
750 Previous Clinical Trials
477,630 Total Patients Enrolled
14 Trials studying Atrial Fibrillation
4,747 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not able to do physical activities.I am under 18 years old.Your left atrial size is larger than 5.5 centimeters.I have severe heart failure.You are currently doing more than 150 minutes a week of moderate to intense exercise.You have been in a heart recovery program in the past year.I am unable to understand and agree to the study's details on my own.I have atrial fibrillation with symptoms, want catheter ablation, and meet at least two other health criteria.I have a health condition that may not let me live beyond a year.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Aggressive Risk Factor Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical benefits are researchers hoping to gain from this clinical trial?
"The primary goal of this trial, which will follow patients for up to 48 months, is to measure the number of hospitalizations related to AF post ablation. Other, secondary outcomes include the number of AF-related hospitalizations (defined as lasting more than 24 hours) from the start of the trial to the end of follow-up, the number of AF-related emergency department visits from the start of the trial to the end of follow-up, and the mean AF burden (defined as the average percentage of time in AF during follow-up, as measured by insertable cardiac monitor)."
Answered by AI
How many study subjects are taking part in this research project?
"That is accurate. As of now, the clinical trial is looking for 670 individuals from a single location. The trial was established on 7/1/2019, with the most recent update being on 7/26/2021."
Answered by AI
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