Comparison of Different Electroporation Systems in the Ablation Treatment of Atrial Fibrillation

NCT ID: NCT06646887

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-05-01

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.

Conditions

AF; Ablation of Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Varipluse,

Varipulse Arm - Participants in this arm will undergo ablation using the Varipulse system

Group Type: ACTIVE_COMPARATOR

Electroporation

Intervention Type: OTHER

Unlike traditional thermal ablation techniques such as radiofrequency (RF) and cryoablation, the electroporation systems used in this study rely on pulsed electric fields (PEF) to selectively target and ablate cardiac tissue. This non-thermal mechanism reduces the risk of collateral damage to nearby structures, such as the esophagus, phrenic nerve, and coronary arteries.

PulseSelect

PulseSelect Arm - Participants in this arm will receive treatment with the PulseSelect system

Group Type: ACTIVE_COMPARATOR

Electroporation

Intervention Type: OTHER

Unlike traditional thermal ablation techniques such as radiofrequency (RF) and cryoablation, the electroporation systems used in this study rely on pulsed electric fields (PEF) to selectively target and ablate cardiac tissue. This non-thermal mechanism reduces the risk of collateral damage to nearby structures, such as the esophagus, phrenic nerve, and coronary arteries.

Farpulse

Farapulse Arm - Participants in this arm will undergo ablation using the Farapulse electroporation system.

.

Group Type: ACTIVE_COMPARATOR

Electroporation

Intervention Type: OTHER

Unlike traditional thermal ablation techniques such as radiofrequency (RF) and cryoablation, the electroporation systems used in this study rely on pulsed electric fields (PEF) to selectively target and ablate cardiac tissue. This non-thermal mechanism reduces the risk of collateral damage to nearby structures, such as the esophagus, phrenic nerve, and coronary arteries.

Interventions

Electroporation

Unlike traditional thermal ablation techniques such as radiofrequency (RF) and cryoablation, the electroporation systems used in this study rely on pulsed electric fields (PEF) to selectively target and ablate cardiac tissue. This non-thermal mechanism reduces the risk of collateral damage to nearby structures, such as the esophagus, phrenic nerve, and coronary arteries.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

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

Significant comorbidities impacting study outcomes.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Dubrava

OTHER

Sponsor Role: lead

Responsible Party

Ana Jordan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Hospital Dubrava, Department of Cardiology

Zagreb, City of Zagreb, Croatia

UHDubrava

Zagreb, , Croatia

Countries

Croatia

References

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.

Reference Type: BACKGROUND

PMID: 33933412 (View on PubMed)

Other Identifiers

2024/0828-4

Identifier Type: OTHER

Identifier Source: secondary_id

Dubrava

Identifier Type: -

Identifier Source: org_study_id