RecruitingNAINTERVENTIONAL

Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI

This study is for people who have a relatively new heart procedure called TAVI (Transcatheter Aortic Valve Implantation) and then develop a new heart rhythm issue called Left Bundle Branch Block (LBBB). Researchers want to find out which follow-up approach works better to keep patients healthy. One approach uses special heart tests (electrophysiology) to guide care, while the other involves standard check-ups and wearing a heart monitor for 30 days at home. The main goal is to see which method is better at reducing problems like fainting spells, needing to go into hospital, or more serious outcomes.

At a glance

Status

Recruiting

Phase

Sponsor

Montreal Heart Institute

Enrolment target

250

Start

15 Oct 2017

Estimated completion

01 Dec 2026

Left Bundle-Branch Block Aortic Valve Stenosis

What is this study about?

When someone has a TAVI procedure to replace a heart valve, sometimes a new heart rhythm problem called Left Bundle Branch Block (LBBB) can happen afterwards. This study is designed to compare two different ways of looking after people who develop this new LBBB.

One group of patients will follow an "electrophysiology-based algorithmic approach." This means doctors will use special, detailed heart tests to understand the heart's electrical signals and decide the best way to manage their condition. The other group will have "standard clinical follow-up," which includes regular check-ups with their doctor and wearing a small, portable heart monitor for about a month to record their heart's activity at home.

The main reason for doing this study is to discover which of these two approaches is more effective in preventing common issues that can happen with LBBB, such as feeling faint or dizzy, needing to be admitted to the hospital, or other more serious health complications. Finding the best way to manage new LBBB after TAVI could help many patients in the future.

Key takeaways

This study compares two ways to manage a new heart rhythm problem (LBBB) after TAVI.
It aims to find out which approach is better at preventing unwanted health issues.
You would be randomly assigned to either detailed heart tests or home heart monitoring.
Participation could help improve care for future patients with similar conditions.
You can leave the study at any time without affecting your normal healthcare.

Who may be eligible?

To join this study, you need to be at least 18 years old and willing to give your permission to be part of the research. A key requirement is that you must have recently had a TAVI heart valve procedure and then developed a new Left Bundle Branch Block (LBBB) rhythm problem that is still present two days after your TAVI.

You would not be able to join the study if you already have a heart pacemaker or a defibrillator fitted. Also, if you had a different type of heart rhythm problem (like Right Bundle Branch Block or LBBB) before your TAVI procedure, you wouldn't be able to participate. Lastly, if your doctors have already decided that you definitely need a pacemaker for specific medical reasons, this study wouldn't be suitable for you.

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 recently had a TAVI heart valve procedure?
Did you develop a NEW LBBB heart rhythm issue after your TAVI, which is still present two days later?
Do you NOT currently have a pacemaker or defibrillator?
Did you NOT have LBBB or another heart rhythm problem called RBBB BEFORE your TAVI?
Have doctors NOT already told you that you definitely need a pacemaker for specific reasons?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first need to sign a consent form, which means you understand what the study involves and agree to participate. You will then be randomly assigned, like flipping a coin, to one of two groups. You'll have an equal chance of being in either group. We don't know which group you'll be in until after you've joined.

One group will have specific heart tests to guide their care, which might lead to having a pacemaker fitted if needed. The other group will have regular check-ups and be asked to wear a sticky patch on their chest for about 30 days. This patch has a small device that records your heart rhythm from home. The total duration of your participation in the study will depend on which group you are in and how your health progresses, as the doctors will be monitoring your condition carefully.

Potential risks and benefits

Participating in this study might offer personal benefits like closer monitoring of your heart health following your TAVI procedure. It could also help doctors learn more about the best way to care for patients like you in the future. As with any medical procedure or monitoring, there are always potential risks, though the study aims to compare established methods. For example, some people in the study might have a pacemaker fitted. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Mazankowski Alberta Heart Institute
Verified postcode
Edmonton, Canada· Recruiting
New Brunswick Heart Center
Verified postcode
Saint John, Canada· Not yet recruiting
QEII Health Sciences Center
Verified postcode
Halifax, Canada· Recruiting
Hamilton Health Sciences Corporation
Verified postcode
Hamilton, Canada· Recruiting
London Health Sciences Center (LHSC)
Verified postcode
London, Canada· Recruiting
University of Ottawa Heart Institute (UOHI)
Verified postcode
Ottawa, Canada· Recruiting
Montreal Heart Institute
Verified postcode
Montreal, Canada· Recruiting
CIUSSS du Nord de l'Île de Mtl
Verified postcode
Montreal, Canada· Recruiting
Centre hospitalier universitaire de Sherbrooke
Verified postcode
Sherbrooke, Canada· Recruiting
Centre Hospitalier Universitaire de Nantes
Verified postcode
Nantes, France· Not yet recruiting

Common questions

What is LBBB?

LBBB stands for Left Bundle Branch Block. It's a condition where the electrical signals that make your heart beat regularly are slowed down or blocked in the left side of your heart.

What is a TAVI procedure?

TAVI (Transcatheter Aortic Valve Implantation) is a way to replace a narrowed or faulty aortic heart valve without open-heart surgery, often done through a small cut in the leg.

Will I definitely get a pacemaker if I join?

Not necessarily. If you're in the group having detailed heart tests, a pacemaker might be fitted if the tests show it's needed. The other group will have different monitoring.

What does a 'transcutaneous cardiac monitor' do?

It's a small device you wear on your chest for about a month. It records your heart's electrical activity while you go about your daily life, to help doctors check your rhythm.

How long will I be involved in the study?

The exact duration will depend on the monitoring and treatment pathway you receive as part of your assigned group. Doctors will check on you carefully throughout.

How to find out more

Léna Rivard, MD, MSc

lena.rivard@umontreal.ca 514-376-3330 Official trial record

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