Active not recruitingNAINTERVENTIONAL

Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

This study is for people who have a heart valve problem called severe aortic stenosis and are preparing for a TAVI procedure. Many people with this condition have hidden heart rhythm problems that doctors might not know about. This study aims to find these issues by continuously monitoring your heart's electrical activity for one week using a small device called CardioSTAT, in the three months leading up to your TAVI. By finding and treating these rhythm problems early, doctors hope to improve your health outcomes, make your recovery from TAVI smoother, and potentially reduce the time you need to spend in the hospital after the procedure. Your heart rhythms will also be checked after the TAVI until you go home, and your health will be followed for up to five years.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Enrolment target

106

Start

01 Jun 2017

Estimated completion

01 Jun 2026

Aortic Valve Stenosis Arrythmia

What is this study about?

This study is for patients who have severe aortic stenosis, a condition where the heart's main valve doesn't open properly, making it harder for blood to flow out to the body. These patients are being considered for a procedure called TAVI (Transcatheter Aortic Valve Implantation), which replaces the faulty valve without open-heart surgery.

Doctors have noticed that many people with severe aortic stenosis also have heart rhythm problems, often without even knowing it. These hidden rhythm issues can sometimes lead to complications during or after the TAVI procedure. The main goal of this study is to find these rhythm problems *before* the TAVI procedure takes place. Finding them early means doctors can plan specific treatments or adjustments to your care, which might lead to better results, fewer complications, and a shorter stay in the hospital after your TAVI.

To do this, you would wear a small, continuous heart monitor (CardioSTAT®) for one week in the months leading up to your TAVI. This monitor will record every beat of your heart. Doctors will then look at this information to see if you have any unusual heart rhythms. After your TAVI, your heart will continue to be monitored in the hospital until you are ready to go home. The doctors will also keep in touch with you for several years after your TAVI to see how you are doing in the long term.

Key takeaways

Study for people with a heart valve condition (aortic stenosis) having a TAVI procedure.
Aims to find hidden heart rhythm problems before TAVI.
Involves wearing a small heart monitor for one week before your TAVI.
Hopes to improve recovery and reduce hospital stays after TAVI.
No new medications are involved in the study.
Long-term follow-up for up to 5 years after TAVI.

Who may be eligible?

This study is for adult patients who have been diagnosed with severe aortic stenosis, a condition where your heart's main valve is narrowed. You must also have been approved by your heart care team to have a TAVI procedure, which is a keyhole surgery to replace this narrowed valve.

However, you might not be able to join if you need to have your TAVI procedure very urgently, or if there's a reason why you can't wear the heart monitor for a full week within three months before your TAVI. Also, if you already have a permanent pacemaker fitted, you won't be able to take part in this study.

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 I have severe aortic stenosis?
Has my heart team approved me for a TAVI procedure?
Could I wear a heart monitor for a full week in the 3 months before my TAVI?
Do I currently have a permanent pacemaker fitted?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will wear a small, continuous heart monitor (CardioSTAT®) for one week. This monitoring will happen sometime within the three months leading up to your TAVI procedure. The monitor is designed to be worn easily under your clothes while you go about your daily activities. You won't need to take any new medications because of this study. After your TAVI procedure, your heart rhythm will be checked in the hospital until you are discharged. Then, you'll have follow-up appointments at 30 days and one year after your TAVI, and then yearly for up to five years, to see how you are doing.

Potential risks and benefits

Participating in this study might help doctors find hidden heart rhythm problems before your TAVI, which could lead to better management and potentially a smoother recovery. However, there are no direct benefits to your health *expected* from taking part, as this is a study to gather information. The main 'involvement' would be wearing the heart monitor for one week; some people might find this slightly inconvenient. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

IUCPQ
Verified postcode
Québec, Canada

Common questions

What is severe aortic stenosis?

It's a condition where the main valve in your heart (aortic valve) has become stiff and narrow, making it harder for your heart to pump blood around your body effectively.

What is a TAVI procedure?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a way to replace your narrowed aortic valve with a new one using a small tube (catheter) inserted through a blood vessel, usually in your leg, without needing open-heart surgery.

What is a heart rhythm problem (arrhythmia)?

It's when your heart beats too fast, too slow, or with an irregular pattern instead of a steady, regular beat.

What is the CardioSTAT® device?

It's a small, portable device that continuously records your heart's electrical activity over an extended period, usually for several days, to detect any abnormal heart rhythms.

How long will I be followed after the TAVI procedure?

You will have check-ups at 30 days and one year, and then yearly for up to a total of five years after your TAVI.