Hello, my name is Roland Tilz. I'm the director of the Department of Rhythmology at the University Heart Center in Lübeck. Today, I'm going to speak about the six months follow-up data of the Volt CE Mark study.

What is the reasoning behind the Volt CE Mark study?

We all know that pulsed field ablation is the energy of the future for catheter ablation of atrial fibrillation. However, first generation PFA tools have several limitations. The Volt balloon hive has been designed to overcome these limitations.

Could you tell us about the unique features of the Volt PFA system?

Unique feature of this catheter is that it's a balloon in basket design which is fully integrated into the 3D mapping system. This has several advantages.

For instance, it's easy to get a very good contact with the tissue: number one. Number two: we have less collateral damage such as hemolysis. Number three: it allows for perfect integration to the 3D mapping system and you better understand the anatomy. And number four: you need only a minimum of PFA applications.You only need two applications per vein for a durable isolation which causes less collateral damage and less hemolysis.

What was the study design and patient population?

In this study, 150 patients with paroxysmal and persistent AF were enrolled. It was a single-arm, multicentre, international study with 11 study sites.

What were the key findings?

The key findings of this study were that acutely, the acute PVI isolation rate was very high; all but one vein could be isolated with the balloon. Number two: the six month follow up was very good, 86% in the paroxysmal AF group and 72% in the persistent AF group remained in sinus rhythm. Number three: the adverse event rate was low with 2.7%.

We had one patient with a cardiac tamponade, two patients with a vascular access complication and one patient who developed [illegible] a couple of days after the procedure. We found that this technology is safe and feasible not only in patients undergoing general anaesthesia, but also in patients sedated with conscious or deep sedation.

In this deep sedation group and conscious sedation group, the number of applications required to isolate the veins was even lower as compared to the GA group.

What are the take-home messages for practice?

So I think the balloon is back. It is the technology of the future. It allows us to get very durable PV isolation at a very good safety profile. And I think it has a very bright future.

What further research is needed in this area?

So now we have to transfer this limited experience into clinical practice. We have to better understand the workflow for the future to streamline the procedure, and we have to demonstrate that [illegible] outside study, this tool is very effective and very safe.