Clinical trial NCT06646887: Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation
Official title: Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: AF
Ablation of Atrial Fibrillation
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The participant is invited to participate in a clinical study comparing three different techniques for treating atrial fibrillation (AF) called electroporation systems. Atrial fibrillation is an irregular heartbeat that can cause complications if left untreated. The goal of this study is to determine which electroporation system is the most effective and safest for treating AF. These systems work by using electrical energy to disrupt abnormal heart tissue, helping to restore a normal heart rhythm.

Detailed description: The investigators are testing three different electroporation systems: Farapulse, PulseSelect, and Varipulse. Each of these systems uses a similar approach to treat AF, but they may work slightly differently. The investigators want to find out which one is best at permanently stopping the irregular heart rhythm, while also being the safest for patients.

What will happen during the study?

The patient will have two procedures:

First procedure: This is the initial ablation, where the doctors will use one of the three electroporation systems to treat the atrial fibrillation. During this procedure, the investigators will map the heart using a special tool to see exactly where the irregular rhythm is happening.

Second procedure: After about 3 months, the participant will return for a re-mapping procedure. This will allow the doctors to check if the treatment was successful and if any abnormal rhythms have come back. If necessary, the investigator will perform another ablation to correct any remaining problems.

Is it safe? All procedures are performed by experienced doctors who specialize in treating AF. Like any medical procedure, there are some risks, such as small chances of blood clots, injury to nearby tissues, or complications from the anesthesia. However, the electroporation systems are designed to minimize these risks, and the study will closely monitor your loved one for any complications.

What are the benefits of participating? The participant could benefit from receiving one of the latest treatments for atrial fibrillation. By participating, they will help doctors learn which system works best, which could help future patients with similar conditions. Additionally, the participant heart rhythm will be closely monitored, and if any problems arise, they will receive immediate care.

How long will it take? The study will last about 6 to 7 months, with the initial procedure taking place in the next few weeks and a follow-up re-mapping procedure approximately 12-14 weeks later.

Eligibility criteria: Patients with symptomatic paroxysmal or persistent atrial fibrillation. Eligible for catheter ablation as per current guidelines. Willing to undergo both an initial ablation procedure and a repeat mapping/ablation if required.

Exclusion Criteria:

Patients with prior ablation procedures. Contraindications for AF ablation (e.g., severe coagulopathy, left atrial appendage thrombus).

Significant comorbidities impacting study outcomes.

Primary outcomes:
measure: Effectiveness and durability of the ablation procedure.
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UHDubrava
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava, Department of Cardiology
Study officials:
References:
citation: Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.