Vision-MR Ablation Catheter 2.0 for the treatment of type I atrial flutter

Zusammenfassung der Studie

The VISABL-AFL clinical trial, sponsored by Imricor Medical Systems, Inc., is a pivotal phase study designed to evaluate the safety and efficacy of radiofrequency (RF) ablation for type I atrial flutter. The trial uses the Vision-MR 2.0 ablation catheter in conjunction with the Osypka HAT 500 RF generator and the irrigation pump. The primary objectives include demonstrating the efficacy and safety of ablations for type I atrial flutter performed with the specified combination of catheter and generator. The study follows a prospective, multicenter, single-arm, interventional design with up to 10 investigative sites in the United States and the European Union. The sample size is set at up to 101 subjects, with the aim of obtaining data from 91 subjects who have met the primary evaluation criteria. An interim analysis is planned after 76 subjects have completed follow-up for the primary evaluation criteria. The total duration of the study is expected to be approximately 12 months, with a recruitment period of 9 months and a follow-up duration of 3 months. Data collection visits include screening/consent, baseline history, the procedure itself, a 7-day post-procedural follow-up, and a 3-month post-procedural follow-up, in person or remotely, if applicable. The trial is designed to evaluate the safety and efficacy of the specified ablation technique and equipment for type I atrial flutter, providing valuable information for future clinical applications.

(BASEC)

Untersuchte Intervention

Before the procedure, several questions will be asked regarding your medical history, symptoms, and the cardiovascular medications you are currently taking to treat your arrhythmia. If your doctor requests, you will need to undergo an imaging exam called "transesophageal echocardiography" to determine if there is a clot requiring treatment in your heart. If a clot is detected, you will need to leave the trial before the procedure.

If you are likely to be pregnant or become pregnant, you will need to take a pregnancy test prior to the ablation procedure. Pregnancy is an exclusion criterion for this clinical study. If the pregnancy test is positive, you will need to leave the study and your doctor will treat your arrhythmia with standard treatment.

The ablation procedure conducted as part of this study will take place in an MRI room. Your preparation for the intervention (including sedation, positioning of adhesive monitoring stickers/patches, punctures in your femoral artery to allow catheter access) may be performed in a room outside of the MRI, according to the protocol in place at your hospital.

Aside from being performed in the MRI and using experimental devices, the ablation procedure will be conducted in the same manner as if it were performed in a traditional X-ray environment with commercially available catheters.

As with a standard atrial flutter ablation procedure in your hospital, this will be done under general anesthesia or deep sedation.

Adhesive ECG electrodes will be placed on your chest and an MRI receiver coil will be positioned above your torso, while a patch will be placed on your leg. You will be connected to a monitoring system that will allow us to track your pulse, blood pressure, and oxygen levels throughout the procedure.

Two catheters will be inserted into a large vein (femoral vein) in your groin and advanced to the right atrium (the upper right chamber) of your heart to record electrical signals, stimulate your heart, and deliver energy (ablation) to the heart.

After the procedure, the catheters will be removed from your groin before you wake up and you will be placed under observation. You will remain under observation until you can safely return to your room. Your recovery will then be identical to that of a conventional procedure.

(BASEC)

Untersuchte Krankheit(en)

Atrial flutter is a type of abnormal heart rhythm characterized by a rapid and regular beating of the atria (the upper chambers of the heart). In atrial flutter, the atria contract quickly but regularly, often at a rate of 250 to 350 beats per minute. This can lead to symptoms such as palpitations, shortness of breath, and sometimes chest pain. Atrial flutter is a cardiac arrhythmia that may require medical treatment to control heart rhythm and rate.

(BASEC)

Sponsor

The sponsor is Imricor Medical Systems, Inc located in the USA. The local representative in Switzerland is the University Hospital Lausanne (CHUV).

(BASEC)

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

Ethikkommission Waadt

(BASEC)

Datum der Bewilligung durch die Ethikkommission

26.02.2024

(BASEC)

Ergebnisse der Studie