RecruitingOBSERVATIONAL

Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation

This study is gathering existing information from different hospitals to learn more about serious problems that can sometimes happen during or shortly after a heart procedure called ablation. This procedure treats fast heartbeats (Ventricular Tachycardia, or VT) or extra heartbeats (Premature Ventricular Complexes, or PVCs). The researchers want to understand who is more likely to experience these complications, what specific details about the procedure might be involved, and how these issues were dealt with by medical staff. The aim is to improve safety for future patients undergoing these important heart treatments.

At a glance

Status

Recruiting

Sponsor

University Hospital, Basel, Switzerland

Enrolment target

15,000

Start

01 Jul 2024

Estimated completion

31 Dec 2028

Ventricular Tachycardia (VT)Premature Ventricular Complexes

What is this study about?

When your heart beats too fast or has extra beats, it's often due to faulty electrical signals. A treatment called ablation uses heat or cold to create tiny scars in the heart muscle to block these signals and help your heart beat normally. While ablation is generally safe and effective, sometimes serious problems can occur during or soon after the procedure.

This study is a bit different from a typical clinical trial where new treatments are tested. Instead, researchers are looking back at information that has already been collected from different hospitals. They want to carefully review the details of patients who experienced a serious complication during or soon after an ablation procedure for fast heartbeats (Ventricular Tachycardia) or extra heartbeats (Premature Ventricular Complexes).

The main goal is to understand why these serious problems happen, who might be more at risk, and how medical teams managed these situations. By gathering and analysing this real-world information from many patients, doctors hope to learn more about how to make ablation procedures even safer for everyone in the future.

Key takeaways

This is a 'look-back' study using existing hospital records, not a new treatment trial.
It aims to understand serious problems that can occur during heart ablation procedures.
Data collected will be about adults (over 18) who had ablations for fast or extra heartbeats.
Patient information will be kept completely anonymous and confidential.
The goal is to improve the safety of future ablation procedures.
No direct patient participation is involved; no new tests or treatments are part of this study.

Who may be eligible?

This study is not looking for new patients to take part. Instead, researchers are reviewing existing medical records and data from various hospitals. They are specifically looking for information about adult patients (over 18 years old) who have already had an ablation procedure for fast or extra heartbeats.

The medical records they're interested in are those where a serious problem occurred during or very soon after the ablation. Examples of serious problems include needing intensive care, a blood clot, a heart attack, or significant bleeding. They will only use data from hospitals that agree to share their anonymous patient information for this research.

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.

I am not directly participating in this study.
My previous medical data (if used) would be about an ablation for fast or extra heartbeats.
My previous medical data (if used) would be about a serious problem during or after that ablation.
I was over 18 years old when I had the ablation procedure.
My personal information will remain anonymous if my data is included.

Answer every question to see your result.

What does participation involve?

You won't be directly involved in this study, as it's not looking for new participants or asking patients to undergo any tests or treatments. This study involves researchers looking at existing, anonymised medical records from hospitals. This means your personal details won't be shared.

If your medical information is included, it will be because you previously had an ablation procedure for fast or extra heartbeats, and a serious problem occurred during or soon after. The information reviewed will be about the procedure and how the complication was managed. There are no visits, assessments, medications, or follow-up appointments required from you for this study. Your participation, if your past data is used, would be completely indirect and anonymous.

Potential risks and benefits

Since this study only involves reviewing existing, anonymous medical records, there are no direct risks or benefits to you as a patient. Your personal identity will be protected, and no new procedures or treatments will be performed. The potential benefit of this research is for future patients: by understanding serious complications better, doctors may be able to make ablation procedures safer and improve patient care in the future. As you are not directly participating, there is no 'right to withdraw' for individual patients whose anonymised data might be included.

Locations (25)

Rush University Medical Center
Verified postcode
Chicago, United States· Recruiting
University of Michigan
Verified postcode
Michigan Center, United States· Recruiting
Medical University of Graz
Verified postcode
Graz, Austria· Recruiting
Université Laval
Verified postcode
Québec, Canada· Recruiting
The First Affiliated Hospital of Nanjing Medical University
Verified postcode
Nanjing, China· Recruiting
University Hospital Center Sestre milosrdnice
Verified postcode
Zagreb, Croatia· Recruiting
CHU Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Centre Hospitalier Universitaire Trousseau
Verified postcode
Chambray-lès-Tours, France· Recruiting
University Hospital Poitier
Verified postcode
Poitiers, France· Recruiting
Clinique Pasteur Toulouse
Verified postcode
Toulouse, France· Recruiting
Zentralklinik Bad Bercka
Verified postcode
Bad Berka, Germany· Recruiting
Uniklinik Freiburg
Verified postcode
Bad Krozingen, Germany· Recruiting

Common questions

What is an 'ablation' procedure?

It's a heart treatment where doctors use energy (like heat or cold) to create tiny scars inside your heart. These scars block faulty electrical signals that cause fast or extra heartbeats, helping your heart beat normally.

What kinds of 'serious problems' are you looking at?

These can include things like needing intensive care, a stroke, a heart attack, serious bleeding, or other issues that need urgent medical attention during or shortly after the ablation.

Will my personal information be shared?

No, absolutely not. The researchers will only look at anonymous information. Your name, address, and any details that could identify you will be removed before any data is used for this study.

Does this study involve new treatments or tests?

No, this study is reviewing information that has already been collected. It's not testing any new treatments or asking anyone to undergo extra tests.

Why is this study important?

By understanding what went wrong in past cases, doctors hope to learn how to make ablation procedures even safer and improve care for all patients who need this treatment in the future.

How to find out more

Michael Kühne, Prof. Dr. med.

michael.kuehne@usb.ch 0041 61 265 52 14 Official trial record

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