Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05328882
Study type Observational
Source University of Split, School of Medicine
Contact Lucija Lisica, MD
Phone +385995094697
Email lucijalisica21@gmail.com
Status Recruiting
Phase
Start date November 17, 2021
Completion date May 17, 2024

See also
  Status Clinical Trial Phase
Completed NCT03545659 - Childhood Acute Lymphoblastic Leukaemia: Follow-Up
Completed NCT04838613 - Study of Diagnostic Performance of [18F]CTT1057 in BCR Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Recruiting NCT04266600 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease N/A
Recruiting NCT04539665 - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease. N/A
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00029185 - Study of Dehydrex in Patients With Corneal Erosion N/A
Completed NCT01351974 - Sentinel Node Biopsy in Breast Cancer Patients N/A
Not yet recruiting NCT06038422 - GTP Regimen in the Treatment of Refractory/Recurrent HLH Phase 3
Withdrawn NCT03162120 - Comparison of Effectiveness of Ranolazine Plus Metoprolol Combination vs. FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation Phase 2/Phase 3
Recruiting NCT04159051 - Charité HT-Prostate N/A
Recruiting NCT02566928 - Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence Phase 4
Completed NCT01989845 - Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer Phase 4
Recruiting NCT01229475 - Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation N/A
Completed NCT00944554 - Relapse Prevention With Varenicline Phase 4
Terminated NCT02247258 - Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence. Phase 2
Completed NCT03654209 - Post-resection Treatment of Large Colon Polyps N/A
Recruiting NCT05557474 - Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit
Active, not recruiting NCT03865537 - Cold Snare Endoscopic Mucosal Resection Trial N/A