Assessment of Catheter Tissue Contact in PFA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrode tissue contact assessment during pulsed field ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Electrode-tissue Contact and Pulmonary Vein Isolation Durability After Pulsed Field Ablation With a Circular "Single Shot" Catheter in Patients With Paroxysmal Atrial Fibrillation
Overview
Pulmonary vein isolation remains the cornerstone of invasive treatment for atrial fibrlllation. Despite recent technological advances in the field of pulsed field ablation (PFA) pulmonary vein isolation durability and arrhythmia free success rates remain approximately at the level of previous years and the radiofrequency ablation era. Isolation durability during PFA procedures might be enhanced by: 1. Intraprocedural monitoring contact of catheter electrode to atrial tissue. 2. Intraprocedural assessment of the transmurality of irreversible electroporation lesion. The aim of our study is to use intracardiac electrogram (iEGM) based analysis for assessment of catheter-tissue contact and PFA lesion durability.
Detailed description
Study design: single group, prospective, observational study. Inclusion criteria and eligibility: patients with paroxysmal atrial fibrillation referred to our center for catheter ablation in accordance with EHRA guidelines and with signed written consent for participation in the study.
Study group: 60 patients divided in two groups. Group 1: initial 10 patients that will have the PFA procedure performed as is stated under Group 1 in the Procedural Protocol section.
Group 2: next 50 patients that will have procedural protocol defined after analysis of procedures in the initial 10 patients.
Procedural protocol:
all patients will have a contrast enhanced computer tomography (CTA) scan of the left atrium performed before the ablation procedure. CTA based left atrial 3D reconstruction will be created with a dedicated segmentation software and fused with the 3D model of the left atrium created during the procedure using the 3D electroanatomical mapping (EAM) system.
Procedures will be performed in deep sedation, using 3D EAM system and intracardiac echocardiography. PFA applications per vein and per antrum will be delivered as specified and recommended by Medtronic. After full lesion set high density mapping of pulmonary veins, venous ostia and antral regions for signs of acute conduction gaps and residual (dormant) conduction within isolation lines will be performed.
Group 1: will include the first 10 patients. First PFA applications per side (left or right) will be delivered in a manual mode (4 manual applications per one full set). An intracardiac electrocardiogram (iEGM) recording period of 30 seconds will be used before the start of applications and a 2 minute iEGM recording period will be used after each of the 4 manual applications with the ablation catheter left in place during the recording. After the first application on each side, applications will be switched to automatic mode and a iEGM recording period of 2 minutes will be used after each automatic application with 30 seconds recording used as the baseline. Recording will include bipolar and unipolar iEGMs. Total number of applications will 32, 4 ostial and 4 antral per vein.
Group 2: will include additional 50 patients. Mode of iEMG recording (bipolar, unipolar, filter settings) and recording time will differ from Group 1 and will be specified based on analysis and correlation of iEGM recordings with acute and longterm conduction gaps.
In this group additional PFA applications will be delivered at ostial/antral regions that will harbor potentially insufficient (nontransmural irreversible electroporation) lesions according to analysis and correlation of iEGM recordings with acute and longterm conduction gaps.
Follow-up (Group 1 and 2) At 6-8 weeks after the procedure all patients will undergo a mandatory reassessment procedure with high density mapping of veins, venous ostia and antral regions for signs of longterm conduction gaps. Any conduction gaps and residual (dormant) conduction within isolation lines will be recorded and tagged on the 3D EAM maps.
Patients will be followed at the outpatient clinic at 3, 6 and 12 months with 7-day holter ECG recordings at each visit.
Outcome measures
1. Assessment of contact (electrode - tissue) based on analysis of intraprocedural characteristics and acute changes of bipolar iEGMs. 2. Assessment of PFA lesion durability based on analysis of intraprocedural characteristics and changes of unipolar iEGMs and information about the presence of conduction gaps from mandatory reassessment procedures.
Study will be conducted in two phases
Phase 1 (duration 1 year):
Obtaining approval of Medical ethics committee Enrolment of 10 patients (group 1) with remap at 6-8 weeks
Phase 2 (duration 2 years) with 1 year follow-up in an out-patient clinic using 7-day holter ECG recordings at 3, 6 and 12 months
Interventions
- Device Electrode tissue contact assessment during pulsed field ablation
Pulsed field ablation (PFA) catheter electrode - tissue contact assessment based on analysis of bipolar intracardiac electrocardiograms: a multipolar PFA catheter will be used for pulmonary vein isolation in a manual mode, which means that instead of delivering fully therapeutic four ablative high voltage pulse trains at each location around pulmonary veins, each of those pulse trains will be delivered manually. Changes (voltage, shape,...) in bipolar intracardiac electrocardiograms (iEGM) measu
Primary outcome measures
- Assessment of contact [Time frame: During index procedure.]
- Assessment of PFA lesion durability [Time frame: From index procedure until 6-8 week mandatory reassessment procedure.]
Secondary outcome measures (1)
- Recurrence of arrhythmia [Time frame: From index procedure until completed 12 month follow-up.]
Eligibility criteria
Inclusion criteria
- Patients with electrocardiographically documented paroxysmal atrial fibrillation (AF), defined according to the European Heart Rhythm Association (EHRA) guidelines
Exclusion criteria
- Contraindication to pulsed field ablation in the left atrium (e.g., presence of a left atrial appendage occlusion device).
- Contraindication to undergoing the procedure under general anesthesia.
- Age >80 years.
- Markedly enlarged left atrium (diameter >50 mm on echocardiography, LAVI >50 mL/m²).
- Life expectancy <1 year.
- Acute life-threatening illness.
- Presence of left atrial thrombus.
- Secondary atrial fibrillation.
- Previous left atrial ablation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University Medical Centre Ljubljana — Ljubljana
Identifiers
NCT: NCT07721948 · ASSESS PFA