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Evaluate the Incidence of Junctional Rhythms Occurring During Post-procedure TAVI Hospitalization.

This study is about a particular type of fast heart rhythm, called a "junctional rhythm," which can sometimes happen after a heart procedure called TAVI. TAVI is a way to replace a narrowed heart valve without open-heart surgery. While TAVI is very good, sometimes heart rhythm problems can occur afterwards. Researchers are observing how often this specific fast heart rhythm appears in patients who have had TAVI at a hospital in France. They also want to understand if having this rhythm means a patient is more likely to need a pacemaker implanted within 30 days of their TAVI operation. The results will help doctors better understand and manage patients after this heart valve treatment.

At a glance

Status
Not yet recruiting
Sponsor
University Hospital, Clermont-Ferrand
Enrolment target
250
Start
05 Oct 2024
Estimated completion
01 May 2025

What is this study about?

Imagine your heart needing a new valve, but instead of major open-heart surgery, doctors can replace it using a less invasive method called TAVI. This procedure places a new valve inside your old one, helping your heart pump blood better. It's a very advanced technique that has helped many people.

However, sometimes after the TAVI procedure, some patients might experience changes in their heart's electrical system, leading to a faster-than-normal heart rhythm. This study is specifically looking at one of these rhythm changes, called a "junctional rhythm." Think of it like a temporary hiccup in the heart's natural electrical signals.

The main goal of this study is simply to observe and understand how often this specific junctional rhythm happens after a TAVI procedure. Doctors are also keen to find out if patients who develop this rhythm are more likely to need a pacemaker fitted within the first month after their TAVI. By gathering this information, healthcare teams can get a clearer picture of what to expect after TAVI and how best to care for patients, ensuring they receive the most appropriate follow-up.

Key takeaways

  • This study investigates a specific heart rhythm change after TAVI.
  • It aims to understand how often this rhythm occurs and if it leads to needing a pacemaker.
  • Participation involves looking at your existing medical records only.
  • There are no direct risks or benefits to you as a participant.
  • The study helps improve future care for TAVI patients.

Who may be eligible?

This study is looking for adults who have had or are about to have a TAVI procedure and who develop a junctional heart rhythm. You need to be at least 18 years old to be considered.

There are certain reasons why you wouldn't be able to take part. For example, if you are under 18, already have a pacemaker, or have a specific irregular heartbeat called atrial fibrillation, you wouldn't be eligible. Pregnant women, people who are under legal guardianship, or those in prison also cannot join.

Importantly, if you do not wish to be part of the study, that is perfectly fine, and you wouldn't be included. Your decision will not affect your medical care.

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.

  1. Are you 18 years old or older?
  2. Did you have a TAVI procedure at Clermont-Ferrand University Hospital?
  3. Did you experience a junctional heart rhythm after your TAVI?
  4. Do you already have a pacemaker? (If yes, you cannot join.)
  5. Did you have another irregular heartbeat called atrial fibrillation? (If yes, you cannot join.)
Answer every question to see your result.

What does participation involve?

If you are eligible, your participation would involve doctors reviewing your medical records from when you had your TAVI procedure at Clermont-Ferrand University Hospital. They would specifically look at your heart monitoring results, like daily ECGs (heart tracings) and telemetry (continuous heart monitoring), to see if you developed a junctional rhythm. If you did, they would then check if you needed a pacemaker within 30 days of your TAVI procedure. You wouldn't need extra tests or follow-up appointments just for this study, as it's looking at information already collected as part of your standard care. The study will look at records for patients treated between December 2023 and March 2025.

Potential risks and benefits

Because this study only involves looking at your existing medical records, there are no direct risks or benefits to you from participating. Your medical care will not change in any way. The benefit of this research is that it helps doctors learn more about the TAVI procedure and how to best care for patients in the future. You always have the right to withdraw your consent for your records to be included in the study at any time, without it affecting your medical treatment.

Locations (2)

  • Centre Hospitalier Universitaire de Clermont-Ferrand
    Verified postcode
    Clermont-Ferrand, France
  • CHU clermont-Ferrand
    Verified postcode
    Clermont-Ferrand, France

Common questions

What is a TAVI procedure?

TAVI is a way to replace a narrowed heart valve using a thin tube, without requiring major open-heart surgery. It helps your heart pump blood better.

What is a junctional rhythm?

It's a specific type of fast or irregular heart rhythm that can sometimes happen after a heart procedure like TAVI. It's a change in the heart's electrical signals.

Why are doctors studying this?

They want to understand how often this specific fast heart rhythm happens after TAVI and if it means someone might need a pacemaker. This helps them better plan patient care.

Do I need to do anything special if I take part?

No, you don't. This study only involves doctors looking at your existing medical information and heart test results that were already recorded during your hospital stay.

Will this study affect my usual heart treatment?

Not at all. Your participation in this study is based on reviewing past information and will not change any of your current or future medical care or treatment.

How to find out more

Lise Laclautre

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

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluate the Incidence of Junctional Rhythms Occurring Durin…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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