Comparison of pulmonary vein isolation procedures using the FARAWAVE Nav catheter without pre-ablation CT versus the conventional Farapulse technique with pre-ablation CT: a controlled, randomized, monocentric study.

Zusammenfassung der Studie

This study aims to compare two different ways of performing a procedure called pulmonary vein isolation, used to treat atrial fibrillation (a heart rhythm disorder). Normally, before the procedure, a CT scan of the heart is performed to clearly see the anatomy of the veins and plan the treatment. However, the CT scan is costly, exposes the patient to radiation, and can slow down the organization of the procedure. In our hospital, we want to understand if a new catheter called FARAWAVE Nav can avoid the CT scan and reduce X-ray exposure during the procedure, thanks to its ability to generate a three-dimensional map of the heart. The energy used (both in the new catheter and the old one) is a type of electrical impulse that does not burn tissues but precisely deactivates them, targeting only the heart muscle. Currently, both catheters are in use at our center, both with excellent efficacy and without one being shown to be superior to the other in terms of effectiveness. However, we want to see if the new catheter, with equal efficacy, can reduce the X-ray exposure typically used during the ablation procedure. Participants will be randomly assigned (like a coin toss) to one of two groups: one group will receive standard treatment with a CT scan before the procedure; the other group will receive the new treatment without a CT scan and with the new catheter. All patients will undergo the procedure in the hospital and will be monitored for about 1–2 days. We want to verify if the new method reduces X-ray time, costs, and the number of applications needed. The study will involve 58 patients. Participation is voluntary and can be stopped at any time. Only adult patients (aged 18 and over) with documented atrial fibrillation can participate. Those who have already had an ablation in the left atrium or are pregnant cannot enter the study.

(BASEC)

Untersuchte Intervention

The FARAPULSE catheter was the first tool of a new technology called pulsed field ablation (PFA) to be used in clinical practice, about three years ago. From the outset, it has proven to be very effective and safe in treating atrial fibrillation. For this reason, it has become the most commonly used catheter in Switzerland for pulmonary vein isolation, a procedure used to treat this heart rhythm disorder.

However, the FARAPULSE belongs to the first generation of these new tools. While still very valid, it has some limitations, particularly that it does not connect to a system that allows for a three-dimensional map of the heart to be seen during the procedure.

In interventional cardiology, many modern catheters can be visualized on special software that reconstructs the heart in 3D. This helps doctors navigate precisely within the heart, reducing risks and improving outcomes.

When a catheter is not compatible with these systems, doctors must rely on fluoroscopy to see where the instruments are located.

Fluoroscopy is a technique that uses X-rays, like an X-ray image, but instead of taking a single image, it records a real-time video. This allows doctors to see how the catheter moves inside the heart. However, fluoroscopy involves radiation exposure for both the patient and the medical team.

For this reason, having catheters that work with three-dimensional maps can help reduce the use of fluoroscopy, improving safety and comfort for everyone.

What is FARAWAVE Nav and why is it innovative?

Our study focuses on a new catheter called FARAWAVE Nav, which represents the second generation of FARAPULSE. Unlike the previous generation, this catheter also allows for real-time mapping of the anatomy and electrical activity of the heart, thanks to a magnetic navigation system. This can make the procedure more precise, faster, and with less need for X-rays.

Additionally, normally, before an ablation, a CT scan of the heart is performed to see the shape of the pulmonary veins. However, the CT scan:

- Exposes the patient to radiation,

- Has significant costs,

- Requires organization and time.

With the new FARAWAVE Nav system, the heart map can be created during the procedure, potentially eliminating the need for a CT scan.

The aim of the study is to understand whether the use of the new catheter without pre-procedure CT is equally effective and safe compared to the traditional method that includes the CT scan.

In particular, we will evaluate:

- The X-ray exposure time during the procedure,

- The total radiation load for the patient,

- The overall procedure time,

- The costs.

The study involves 58 patients with atrial fibrillation. Each participant will be randomly assigned (like a coin toss) to one of two groups:

- Standard group: receives ablation with the traditional FARAPULSE catheter and with a CT scan before the procedure.

- Innovative group: receives ablation with the new FARAWAVE Nav catheter without undergoing a CT scan.

(BASEC)

Untersuchte Krankheit(en)

Atrial fibrillation The heart has a natural rhythm, like a metronome, that regulates each beat in an orderly manner. This rhythm is managed by electrical signals that start from an area called the "sinoatrial node" and spread throughout the heart, causing it to contract regularly. In atrial fibrillation (AF), this electrical system no longer functions correctly. The atria, which are the two upper chambers of the heart, begin to beat irregularly and often too quickly. The heartbeat becomes "chaotic," and the heart no longer pumps blood efficiently. Atrial fibrillation is the most common arrhythmia in the adult population, especially after the age of 60. It can manifest with symptoms such as: - Palpitations (the sensation that the heart is "racing" or "skipping"), - Fatigue even with small efforts, - Shortness of breath, - Dizziness or weakness, - Anxiety or discomfort in the chest. In some people, fibrillation is continuous, while in others, it occurs in episodes, even brief ones. Although some cases may not present symptoms, atrial fibrillation increases the risk of blood clots forming in the heart, which can then cause a stroke. How does atrial fibrillation develop? Often, the abnormal electrical signals that trigger atrial fibrillation originate from the pulmonary veins, which are the veins that carry blood from the lungs to the heart. These veins drain into the left atrium, and some cells within them can generate abnormal electrical impulses that disrupt the heart's rhythm. How is atrial fibrillation treated? The first line of treatment involves medications or ablation. Medications aim to: - Control the heart rate (so it does not beat too quickly), - Maintain a normal rhythm, - Prevent the formation of clots, often through anticoagulants. However, in many patients, medications are insufficient or not tolerated due to side effects. In these cases, a procedure called ablation may be proposed. What is ablation? Ablation for atrial fibrillation is a minimally invasive procedure aimed at "deactivating" the areas of the heart from which the abnormal electrical signals originate. It is an interventional procedure: the doctor inserts catheters (thin tubes) into a vein in the leg and guides them to the left atrium of the heart. Once in the left atrium, a type of energy is used to "isolate" the pulmonary veins, creating a ring around each vein to block the passage of abnormal electrical impulses. This aims to restore and maintain the normal rhythm of the heart. What type of energy is used? Traditionally, radiofrequency energy (heat) or cryoenergy (cold) was used. Recently, a new type of energy called pulsed field ablation (PFA) has been introduced. This technique does not burn or freeze tissues. Instead, it uses very brief electrical pulses to create pores in the heart cells, leading to their death very precisely. This method only targets cardiac muscle tissue, sparing nearby structures such as nerves, the esophagus, or veins. This type of energy is currently the safest and most effective for isolating the pulmonary veins.

(BASEC)

Sponsor

Istituto Cardiocentro Ticino - Ente Ospedaliero Cantonale

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Tessin

(BASEC)

Datum der Bewilligung durch die Ethikkommission

17.09.2025

(BASEC)

Ergebnisse der Studie