Active not recruitingNAINTERVENTIONAL

Reversal of Atrial Substrate to Prevent Atrial

This study wants to find out the best way to stop an irregular heartbeat called atrial fibrillation (AF) from coming back. It compares two groups of people with AF who are having a treatment called catheter ablation. One group will have the standard catheter ablation, and the other group will also have a special programme to manage their health and lifestyle factors, such as blood pressure and weight. The research aims to see if tackling these health factors at the same time as ablation can better prevent AF recurrence. This could help doctors develop better ways to treat AF and improve patients' lives.

At a glance

Status

Active not recruiting

Phase

Sponsor

Nova Scotia Health Authority

Enrolment target

509

Start

01 Jul 2019

Estimated completion

31 Dec 2027

Atrial Fibrillation

What is this study about?

Atrial fibrillation (or AF) is a common condition where your heart has an irregular and often very fast heartbeat. This can cause symptoms like tiredness, dizziness, and feeling out of breath. For some people, it can increase the risk of more serious problems like strokes. There are treatments available for AF, but for many people, the condition can come back.

This study is trying to find the best way to prevent AF from returning. Doctors know that certain lifestyle choices and health conditions, such as high blood pressure, being overweight, or not exercising enough, can make AF more likely or harder to treat. The study wants to see if actively managing these factors, alongside a common treatment called catheter ablation, can be more effective than ablation alone.

Catheter ablation is a procedure where doctors use heat or cold to create tiny scars in a small area of your heart. This helps to block faulty electrical signals that cause the irregular heartbeat. By comparing the results of people who have ablation with those who also get intensive support to improve their health and lifestyle, researchers hope to discover if this combined approach leads to a longer-lasting solution for AF.

Key takeaways

This study is for people with symptomatic atrial fibrillation (AF).
It aims to find the best way to prevent AF from coming back.
It compares standard catheter ablation with ablation plus an intensive lifestyle programme.
Participation requires meeting certain health and lifestyle criteria.
You will be randomly assigned to one of the two treatment groups.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have had symptoms of atrial fibrillation (AF), which means their heart has an irregular beat. You should be interested in having a treatment called catheter ablation for your AF.

To join, you also need to have at least two of the following: a body mass index (BMI) of 27 or more, high blood pressure (readings of 140/90 mmHg or higher, or a history of being treated for high blood pressure), a past stroke or mini-stroke, diabetes, a history of heart failure (especially if you've been admitted to hospital for it or your heart's pumping ability is below 40%), or be aged 65 or older. Current smokers and those who drink a lot of alcohol are also eligible.

You cannot join if your AF has been constant for more than three years, or if you've had catheter ablation for AF before. You also can't take part if you have very severe heart failure, have been in a heart rehabilitation programme in the last year, or if you already do more than 150 minutes of moderate to strong exercise each week. You must also be able to exercise, able to give your clear agreement to take part, and be expected to live for at least another year.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have symptomatic atrial fibrillation (irregular heartbeat)?
Are you considering catheter ablation for your AF?
Are you 18 years old or older?
Do you have at least two of these: BMI of 27+, high blood pressure, a history of stroke/mini-stroke, diabetes, heart failure, or are aged 65+?
Have you not had a catheter ablation for AF before?
Are you currently not doing more than 2 and a half hours of moderate to strong exercise per week?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups. This is like flipping a coin, so it's fair. Both groups will have a treatment called catheter ablation for their AF.

One group will have their catheter ablation within three months of joining the study. The other group will first take part in a 12-week (about three month) programme at home, focusing on exercise and managing health factors like diet and blood pressure. After this programme, they will then have their catheter ablation. This first part of the study lasts for about five months.

Throughout the study, doctors and nurses will regularly check your progress and monitor your AF. They will also look at how your general health and lifestyle factors change. You will have follow-up appointments and checks for a longer period to see how well the treatments are working in the long term. The study team will explain all the visits, tests, and how long you'll be involved in full detail.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical attention and potentially a more effective way to manage your atrial fibrillation, which could improve your quality of life. However, catheter ablation, like all medical procedures, carries some risks, such as bleeding, infection, or damage to the heart, though these are rare. The study also involves making lifestyle changes, which can be challenging. You are a volunteer and have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

Foothills Hospital
Verified postcode
Calgary, Canada
Mazankowski Alberta Heart Institute
Verified postcode
Edmonton, Canada
Kelowna General Health
Verified postcode
Kelowna, Canada
St. Paul's Hospital
Verified postcode
Vancouver, Canada
Saint John Regional Hospital
Verified postcode
Saint John, Canada
QE II Health Sciences Centre
Verified postcode
Halifax, Canada
Hamilton Health Sciences Center
Verified postcode
Hamilton, Canada
St. Mary's General Hospital
Verified postcode
Kitchener, Canada
London Health Sciences Center
Verified postcode
London, Canada
Ottawa Heart Institute
Verified postcode
Ottawa, Canada
St. Michael's Hospital
Verified postcode
Toronto, Canada
Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada

Common questions

What is atrial fibrillation?

It's an irregular and often fast heartbeat that can make you feel tired or dizzy. It can sometimes increase your risk of stroke.

What is catheter ablation?

It's a procedure where a doctor uses special tools to create tiny scars in your heart to correct the faulty electrical signals that cause AF.

What does 'aggressive risk factor control' mean?

It means actively working to improve health issues like high blood pressure, being overweight, or lack of exercise through a special programme.

Will I definitely get the new combined treatment?

You'll be randomly assigned to one of two groups: either catheter ablation on its own, or ablation combined with the intensive health programme.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time without it affecting your other medical care.