Early Recurrences of Atrial Arrhythmias and Their Impact on Late Recurrence After Pulmonary Vein Isolation With Pulsed Field Ablation of Paroxysmal Atrial Fibrillation

October 4, 2023 updated by: Lucija Lisica, University of Split, School of Medicine
This is a prospective, single-arm study conducted in University Hospital of Split, Department of Cardiology. Patients treated with PFA for symptomatic paroxysmal atrial fibrillation will be asked to participate in the study. An implantable loop recorder (ILR) will be placed immediately after the PFA procedure for rhythm monitoring. Early recurrences will be subsequently divided into very early recurrences (up to 1 month post-procedure) and early recurrences (1-3 months post-procedure). Late recurrences will be defined as those 3 to 12 months post-procedure. Patients will be monitored routinely through follow up visits during which ILR will be interrogated and eventual symptoms will be assessed. Follow-up visits will be scheduled 1, 3, 6, 12 months post-procedure. Median follow-up will be 12 months. Data for the study will be obtained from a loop monitor to assess the arrhythmia burden during follow-up visits in the University Hospital of Split Arrhythmia Clinic.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm study conducted in the University Hospital of Split, Department of Cardiology. Patients treated with PFA for symptomatic paroxysmal atrial fibrillation will be asked to participate in the study. An implantable loop recorder (ILR) will be placed immediately after the PFA procedure for rhythm monitoring. Early recurrences will be subsequently divided into very early recurrences (up to 1-month post-procedure) and early recurrences (1-3 months post-procedure). Late recurrences will be defined as those 3 to 12 months post-procedure. Patients will be monitored routinely through follow-up visits during which ILR will be interrogated and eventual symptoms will be assessed. Follow-up visits will be scheduled 1, 3, 6, and 12 months post-procedure. The median follow-up will be 12 months. Data for the study will be obtained from a loop monitor to assess the arrhythmia burden during follow-up visits in the University Hospital of Split Arrhythmia Clinic.

For PVI, the "single-shot" multielectrode PFA catheter will be used. This catheter consists of 5 splines, with 4 electrodes per spline and 1 electrode available for intracardiac electrogram recording or 3-dimensional electroanatomic visualization. When used in conjunction with the PFA generator, an electric field is created that ablates tissue using irreversible electroporation. The catheter shape is changed through the manipulation of a slider mechanism on the handle of the catheter. The diameter of the catheter is measured in the fully deployed "flower" configuration and is available in 2 sizes (31 or 35 mm). Energy is delivered through all of the electrodes in a proprietary sequence.

All patients will be asked to provide written informed consent for their respective protocol before undergoing the study.

All procedures will be performed with conscious sedation and propofol bolus synchronized to sets of PFA applications. The procedures will be performed with uninterrupted oral anticoagulation, and left atrial thrombus will be excluded either through pre-procedure CT or intracardiac echocardiography (ICE) (AcuNav, Siemens, Munich, Germany) at the time of the procedure. Pre- and post-ablation diaphragm motion will be evaluated to observe changes in phrenic nerve function during the procedure. Esophageal temperature monitoring will not be utilized due to the nonthermal nature of PFA.

A single transseptal puncture will be performed with an 8.5-F sheath and exchanged for the 13-F PFA sheath in the left atrium, or a transseptal puncture will be performed directly with the PFA sheath. Intravenous heparin will be administered as boluses and continuous infusions to obtain an activated clotting time ≥300 s prior to ablation and throughout the procedure. A 0.035-inch, 180-cm extra-stiff, straight guidewire will be used to cannulate each vein over which the multielectrode PFA catheter will be deployed into the desired shape and advanced into position at the antrum of each vein. The antral level of catheter positioning will be monitored with ICE imaging and fluoroscopy. Patients with left common PV anatomy will receive therapy at the level of the common antrum with 2 sets of therapy delivered, 1 with the guidewire in a superior branch and 1 with the guidewire in an inferior branch.

Acute isolation of the treated vein will be determined by the mapping electrodes on each spline of the PFA catheter. Once all veins have been treated, a 3-dimensional electroanatomic voltage map will be created to confirm PV isolation and visualize the level of isolation of each lesion set. Entrance or exit block will be confirmed following a 20-min wait period after the last PFA application was delivered with a circular mapping catheter (Lasso, Biosense Webster, Irvine, California).

All patients will be implanted with an ILR (Medtronic Reveal LINQTM; Medtronic, Minneapolis, MN). After ablation procedure, the ILR will be inserted subcutaneously in the left fourth intercostal space. The procedure itself takes up to 15 minutes and local anesthetic will be administered prior to the implantation. The antiarrhythmic drugs, except beta-blocker, will be routinely discontinued.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zrinka Jurišić, Ass. Prof., MD
  • Phone Number: +385915262844
  • Email: zrinkacn@gmail.com

Study Locations

  • Croatia
    • Splitsko-dalmatinska
      • Split, Splitsko-dalmatinska, Croatia, 21000
        • Recruiting
        • University Hospital Center Split
        • Contact:
        • Principal Investigator:
          • Lucija Lisica, MD
        • Sub-Investigator:
          • Ivan Sikiric, MD
        • Sub-Investigator:
          • Ante Anic, MD
        • Sub-Investigator:
          • Toni Breskovic, MD, PhD
        • Sub-Investigator:
          • Zrinka Jurisic, Ass. Prof., MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic paroxysmal atrial fibrillation after at least one failed or intolerant group I or III of antiarrhythmic drug that are eligible for PFA and are willing and able to provide informed consent.

Description

Inclusion Criteria:

  • Age >18
  • Index PFA procedure after one failed or intolerant group I or III of the antiarrhythmic drug in patients with symptomatic paroxysmal AF (AF with self-terminating episodes lasting no longer than 7 continuous days)
  • Willing and able to provide informed consent.

Exclusion Criteria:

  • Any known contraindication to AF ablation or anticoagulation.
  • History of previous left atrial ablation or surgical treatment.
  • Secondary AF due to reversible or non-cardiac cause such as thyroid disease and electrolyte imbalance.
  • Asymptomatic AF patients, persistent AF, permanent AF patients.
  • History of clotting or bleeding disease or cryoglobulinemia.
  • Pregnant or lactating.
  • Other conditions that may make the patient a poor candidate for procedure such as mental illness, terminal illness, vulnerable patient population.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ERAF after PFA
Patients with an early recurrence after pulsed field ablation of paroxysmal atrial fibrillation.
Other: Monitoring of paroxysmal atrial fibrillation recurrence after pulsed field catheter ablation
The implanted loop recorder will be interrogated to see how many patients had an early recurrence of AF (up to 3 months after the procedure). Then the late recurrence rate will be compared (3-12 months post-procedure) between groups with and without early recurrences.
no ERAF after PFA
Patients without an early recurrence after pulsed field ablation of paroxysmal atrial fibrillation.
Other: Monitoring of paroxysmal atrial fibrillation recurrence after pulsed field catheter ablation
The implanted loop recorder will be interrogated to see how many patients had an early recurrence of AF (up to 3 months after the procedure). Then the late recurrence rate will be compared (3-12 months post-procedure) between groups with and without early recurrences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with AF recurrence 3-12 months post-procedure
Time Frame: 12 months
Number of participants with AF recurrence 3-12 months post-procedure (AF burden defined by loop recorder findings)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate
Time Frame: 12 months
Adverse event rate defined as any untoward medical occurrence, unintended disease or injury related to all aspects of the ablation procedure (death, air embolism, myocardial infarction, stroke, esophageal injury, PV stenosis, puncture site hematoma, vascular lesions).
12 months
Number of patients with very early AF recurrence (within 1 month post procedure)
Time Frame: 12 months
Number of patients with very early AF recurrence (within 1 month post procedure)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Estimated)

May 17, 2024

Study Completion (Estimated)

May 17, 2024

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181-147/01/06/M.S.-21-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication will be shared.

IPD Sharing Time Frame

The data will become available immediately after the publication of the study.

IPD Sharing Access Criteria

The plan will be shared with other researchers who wish to replicate the study or study the protocol in detail.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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