Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation

Официальное название

A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulse Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation

Обзор

The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior/RF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.

Вмешательства

• Процедура PF-only PVI
  It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only PF energy for ablation
• Процедура Hybrid PVI
  It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing both PF and RF energy for ablation. Specifically, PF energy is used for the posterior segments and RF energy for the anterior segments of the pulmonary veins
• Процедура RF-only PVI
  It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only RF energy for ablation

Первичные конечные точки

• Acute HRV variation (PF-only vs. RF-only arm) [Срок оценки: from enrolment to the day after the ablation procedure]

Вторичные конечные точки (1)

• Acute HRV variation (Hybrid vs. RF-only arm) [Срок оценки: from enrolment to the day after the ablation procedure]

Критерии участия

Критерии включения

• Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset
• Age range: 18-70 years
• Willing and capable of providing informed consent
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Критерии исключения

• Previously diagnosed Persistent AF (\> 7 days in duration)
• Previous LA ablation
• Previous cardiac surgery
• Myocardial Infarction within the previous 3 months
• Severely compromised Left Ventricular Ejection Fraction (LVEF\<40%)
• Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
• Acute illness, active systemic infection, or sepsis
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
• Severe mitral regurgitation
• Woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• OLV Hospital — Aalst

Идентификаторы

NCT: NCT06647485 · GPfIRE01-BWI-CS-012 · CIV-24-02-046139-RS01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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