NCT06646887

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

October 2, 2024

Last Update Submit

March 28, 2025

Conditions

AFAblation of Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Effectiveness and durability of the ablation procedure.

    The percentage of patients who achieve complete and durable pulmonary vein isolation without reconnection, confirmed during the re-mapping procedure performed approximately 12-14 weeks after the initial ablation.

    Three months

Study Arms (3)

Varipluse,

ACTIVE COMPARATOR

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

Other: Electroporation

PulseSelect

ACTIVE COMPARATOR

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

Other: Electroporation

Farpulse

ACTIVE COMPARATOR

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

Other: Electroporation

Interventions

ElectroporationOTHER

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.

FarpulsePulseSelectVaripluse,

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients with prior ablation procedures. Contraindications for AF ablation (e.g., severe coagulopathy, left atrial appendage thrombus).
  • Significant comorbidities impacting study outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Hospital Dubrava, Department of Cardiology

Zagreb, City of Zagreb, 10000, Croatia

Location

UHDubrava

Zagreb, 10 000, Croatia

Location

Related Publications (1)

  • 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.

    PMID: 33933412BACKGROUND

MeSH Terms

Interventions

Electroporation

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 17, 2024

Study Start

October 15, 2024

Primary Completion

April 10, 2025

Study Completion

May 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Patient Privacy and Confidentiality: Sharing detailed individual data can raise concerns about the privacy of participants. Even with de-identification, there may be a risk of re-identifying participants, especially with a relatively small sample size and specific medical conditions like atrial fibrillation. Ethical Considerations: Ethical guidelines often require that participant data is protected and only used for the specific purposes outlined in the consent forms. Sharing IPD might exceed the scope of what participants agreed to when they enrolled in the study. Regulatory Restrictions: Some regulatory bodies or institutions may impose strict guidelines on the sharing of sensitive medical data to prevent misuse or ensure data security, particularly when dealing with experimental procedures or novel technologies like electroporation systems.

Locations

CR(2)