RecruitingNAINTERVENTIONAL

Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

This study is investigating two main treatments for an irregular heartbeat called atrial fibrillation (AF) in people who also have heart failure, specifically those where the heart muscle pumps fairly well. Participants will be randomly given either a procedure called catheter ablation, which tries to restore a normal heart rhythm, or daily medicines that control the heart rate. For people with AF and heart failure, it's not fully clear which approach is best. This initial 'pilot' phase of the study will help researchers decide if a larger study is possible. Ultimately, the goal is to find out which treatment leads to a better quality of life, fewer hospital visits, and potentially helps people live longer.

At a glance

Status

Recruiting

Phase

Sponsor

Nova Scotia Health Authority

Enrolment target

Start

01 Jan 2026

Estimated completion

01 Oct 2027

Atrial Fibrillation (AF)Heart Failure With Mildly Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction (HFPEF)Rate Control Rhythm Control

What is this study about?

You might be reading this because you or someone you know has been diagnosed with Atrial Fibrillation (AF) and also has a type of heart failure where the heart's pumping action is still quite good. AF causes your heart to beat irregularly and often too fast, which can make you feel tired or breathless. Heart failure means your heart isn't pumping blood as effectively as it should, leading to symptoms like swelling or breathlessness.

Doctors currently use different approaches to manage AF in people with heart failure. One approach is 'rhythm control,' which aims to get your heart back to a normal, steady rhythm. In this study, rhythm control involves a procedure called catheter ablation. This procedure uses heat or cold to create tiny scars in your heart tissue, blocking the faulty electrical signals that cause AF. The other approach is 'rate control,' which means keeping your heart rate from going too fast, even if it's still irregular. This is typically done using daily medications like beta-blockers or calcium channel blockers.

Right now, it's not definitively known which of these strategies — ablation or medication — is better for people who have both AF and this specific type of heart failure. This study wants to find out which treatment might lead to better health outcomes, such as a better quality of life, fewer hospital stays, and improved survival. This first stage of the study is a 'pilot' to check if a bigger study can be run successfully and if enough people would be interested in taking part.

Key takeaways

The study compares a procedure (ablation) with medicines for an irregular heartbeat.
It's for people who also have a specific type of heart failure.
The goal is to find out which approach improves quality of life and reduces hospital stays.
Participants will be randomly assigned to one of the two treatments.
This is a pilot study to see if a larger study is possible.
All study treatments and visits will be carefully monitored by doctors.

Who may be eligible?

To be considered for this study, you would generally need to be at least 18 years old and have a confirmed diagnosis of atrial fibrillation (an irregular heartbeat). You also need to have heart failure that is causing mild to moderate symptoms (doctors use something called NYHA class II-III to describe this), and your heart's main pumping chamber must be working reasonably well (meaning your left ventricular ejection fraction is above 40%). Chemical markers in your blood, specifically NT-proBNP, would also need to be at certain levels indicating some strain on your heart.

There are several reasons why someone might not be able to join the study. For example, if you have a type of AF that is considered 'permanent' and unlikely to respond to rhythm treatment, or if you've already had a catheter ablation for AF, you wouldn't be eligible. Also, if your heart failure is very severe (NYHA class IV) or if you have certain other heart conditions like severe problems with your heart valves, you wouldn't be able to take part.

Other reasons for not being able to join include having kidney failure that needs dialysis, conditions like untreated thyroid disease, or if you've had a recent heart attack or major heart surgery. If you're involved in another research study or have any other serious health condition that might significantly shorten your life, you also wouldn't be able to participate.

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.

Are you 18 years old or older?
Have you been diagnosed with an irregular heartbeat called atrial fibrillation?
Do you have heart failure where your heart's pumping action is still fairly strong?
Are you able to take blood-thinning medicine if prescribed?
Have you *not* had previous heart surgery for your irregular heartbeat?
Are you able to commit to regular hospital visits for check-ups and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the criteria. If you are eligible, you would then be randomly assigned to one of two treatment groups: either you would receive catheter ablation to try and restore a normal heart rhythm, or you would be given daily medications to control the rate of your heartbeat. This random assignment means neither you nor the doctors can choose which group you join.

Throughout the study, you would have regular visits with the study team. These visits will involve various tests and assessments to monitor your heart health, check for any changes in your symptoms, and see how well the treatment is working. This might include blood tests, ECGs (heart tracings), and questionnaires about your quality of life. The study duration for each participant is not specified but generally involves ongoing follow-up for a period to assess the long-term effects of the treatments. You would be given detailed information about the schedule of visits and assessments if you decide to consider joining.

Potential risks and benefits

Taking part in any study involves careful consideration. Potential benefits might include closer monitoring of your heart condition and access to a specific treatment strategy that could improve your symptoms, quality of life, or even survival, depending on which treatment turns out to be more effective. However, there are also potential risks related to the treatments themselves, such as the risks associated with catheter ablation (like bleeding, infection, or heart damage, though these are rare) or potential side effects from the medications. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

QEII HSC
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is atrial fibrillation?

It's an irregular and often very fast heartbeat in the upper chambers of your heart.

What is heart failure with preserved ejection fraction?

This is a type of heart failure where your heart pumps normally but has trouble relaxing and filling with blood.

What is catheter ablation?

It's a procedure that uses heat or cold to create small scars in the heart, blocking signals that cause irregular heartbeats.

What do 'rate control' and 'rhythm control' mean?

Rate control uses medicines to slow a fast heart, while rhythm control aims to get your heart back to a steady, normal beat.

Will I get to choose my treatment?

No, you would be randomly assigned to either the ablation or medication group, like flipping a coin.

How to find out more

Laura Hamilton, BSC, MAHSR

laura.hamilton@nshealth.ca 902-473-7226 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.