670 Participants Needed

Aggressive Risk Factor Management for Atrial Fibrillation

(RASTA AF Trial)

Recruiting at 15 trial locations
LM
RP
Overseen ByRatika Parkash, MD FRCPC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

A multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on recurrence of atrial fibrillation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is aggressive risk factor management for atrial fibrillation safe for humans?

The research supports that managing lifestyle and risk factors is a key part of treating atrial fibrillation, and international guidelines recommend it as a safe and effective approach to improve outcomes and reduce risks like stroke and heart failure.12345

How does the Aggressive Risk Factor Management treatment for atrial fibrillation differ from other treatments?

Aggressive Risk Factor Management for atrial fibrillation is unique because it focuses on modifying lifestyle and managing risk factors like obesity, sleep apnea, and high cholesterol, rather than just using medication or procedures. This comprehensive approach aims to reduce symptoms and improve outcomes by addressing the root causes of the condition.24678

What data supports the effectiveness of the treatment Aggressive Risk Factor Management for Atrial Fibrillation?

Research shows that managing lifestyle and risk factors can improve outcomes for people with atrial fibrillation (AF). Effective lifestyle management can help stop and even reverse the progression of AF, and it increases the chances of staying free from irregular heartbeats after certain procedures.23469

Who Is on the Research Team?

MR

Michiel Rienstra

Principal Investigator

University of Groningen

Iv

Isabelle vanGelder

Principal Investigator

University of Groningen

JR

Jennifer Reed

Principal Investigator

University of Ottawa Heart Institution

AT

Anthony Tang

Principal Investigator

London Health Sciences Centre

VE

Vidal Essebag

Principal Investigator

McGill University Hospital

AS

Allan Skanes

Principal Investigator

London Health Sciences Centre

JS

John Sapp

Principal Investigator

Nova Scotia Health Authority

JH

Jeff Healey

Principal Investigator

Hamilton Health Sciences Centre

RP

Ratika Parkash

Principal Investigator

Nova Scotia Health Authority

CB

Chris Blanchard

Principal Investigator

Nova Scotia Health

GW

George Wells

Principal Investigator

University of Ottawa Heart Institution

DB

David Birnie

Principal Investigator

University of Ottawa Heart Institution

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have atrial fibrillation with symptoms, want catheter ablation, and meet at least two other health criteria.

Exclusion 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.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation and/or aggressive risk factor management for atrial fibrillation

5 months
Multiple visits for ablation and risk factor management

Blinding Period

A 2-month blanking period post-ablation to stabilize treatment effects

2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including AF events and quality of life assessments

Up to 72 months

What Are the Treatments Tested in This Trial?

Interventions

  • Aggressive Risk Factor Control
  • Standard of Care
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Aggressive Risk Factor ControlExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Aggressive Risk Factor Control is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Aggressive Risk Factor Control for:
🇺🇸
Approved in United States as Aggressive Risk Factor Control for:
🇨🇦
Approved in Canada as Aggressive Risk Factor Control for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Phillips

Collaborator

Trials
1
Recruited
670+

Cardiac Arrhythmia Network of Canada

Collaborator

Trials
14
Recruited
8,400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Abbott

Industry Sponsor

Trials
760
Recruited
489,000+
Dr. Etahn Korngold profile image

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford profile image

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Ottawa Heart Institute Research Corporation

Collaborator

Trials
200
Recruited
95,800+

Published Research Related to This Trial

Atrial fibrillation (AF) management should include a comprehensive approach that focuses on modifying multiple risk factors, as this is crucial for preventing the progression of the condition.
Effective lifestyle management not only helps to reverse AF progression but also improves the chances of successful outcomes after catheter ablation procedures.
Lifestyle Modification and Atrial Fibrillation: Critical Care for Successful Ablation.Fitzgerald, JL., Middeldorp, ME., Gallagher, C., et al.[2022]
Only 4.0% of the 17,898 patients with atrial fibrillation (AF) studied maintained a healthy lifestyle, which includes factors like not smoking and having controlled blood pressure and glucose levels.
Patients with modifiable risk factors, such as current smoking and poorly controlled blood pressure or glucose, faced significantly higher risks of all-cause mortality and nonfatal ischemic stroke, highlighting the importance of lifestyle management in improving outcomes for AF patients.
Prevalence of modifiable risk factors and relation to stroke and death in patients with atrial fibrillation: A report from the China atrial fibrillation registry study.Jiang, C., Lan, DH., Du, X., et al.[2020]
Anticoagulation therapy, such as warfarin, can reduce the risk of stroke in patients with atrial fibrillation by 62%, making it a crucial treatment option for high-risk individuals.
Guidelines recommend tailored antithrombotic therapy based on individual stroke risk factors, with high-risk patients benefiting most from anticoagulation, while low-risk patients may only need aspirin.
Comparing the guidelines: anticoagulation therapy to optimize stroke prevention in patients with atrial fibrillation.Rockson, SG., Albers, GW.[2013]

Citations

Lifestyle Modification and Atrial Fibrillation: Critical Care for Successful Ablation. [2022]
Prevalence of modifiable risk factors and relation to stroke and death in patients with atrial fibrillation: A report from the China atrial fibrillation registry study. [2020]
Comparing the guidelines: anticoagulation therapy to optimize stroke prevention in patients with atrial fibrillation. [2013]
Occurrence and characteristics of stroke events in the Atrial Fibrillation Follow-up Investigation of Sinus Rhythm Management (AFFIRM) study. [2022]
Improving outcomes in patients with atrial fibrillation: rationale and design of the Early treatment of Atrial fibrillation for Stroke prevention Trial. [2013]
Four-year incidence of major adverse cardiovascular events in patients with atherosclerosis and atrial fibrillation. [2021]
Association of pulmonary vein isolation and major cardiovascular events in patients with atrial fibrillation. [2022]
Lifestyle modifications for treatment of atrial fibrillation. [2020]
Obesity, Exercise, Obstructive Sleep Apnea, and Modifiable Atherosclerotic Cardiovascular Disease Risk Factors in Atrial Fibrillation. [2022]
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