Clinical trial NCT06647485: Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Paroxysmal AF
Keywords: vagal modulation
ganglionated plexi
pulsed field
dual-energy focal ablation
paroxysmal atrial fibrillation
heart rate variability
pulmonary vein isolation
Lead sponsor: VZW Cardiovascular Research Center Aalst
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2024-10-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previously diagnosed Persistent AF (\&gt; 7 days in duration)
* Previous LA ablation
* Previous cardiac surgery
* Myocardial Infarction within the previous 3 months
* Severely compromised Left Ventricular Ejection Fraction (LVEF\&lt;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

Primary outcomes:
measure: Acute HRV variation (PF-only vs. RF-only arm)
timeFrame: from enrolment to the day after the ablation procedure
Secondary outcomes:
measure: Acute HRV variation (Hybrid vs. RF-only arm)
timeFrame: from enrolment to the day after the ablation procedure
Other outcomes:
measure: Acute difference in biomarker release
timeFrame: Peri-procedural: from procedure start (after groin puncture) to its end (before sheaths removal)
measure: Atrial arrhythmia recurrences and atrial fibrillation burden
timeFrame: from day 91 to day 365 post-ablation
measure: Acute difference in resting Heart Rate (HR)
timeFrame: from enrolment to the day after the ablation procedure
measure: HRV variation across the follow-up period
timeFrame: from the first follow-up (3-month) visit until the last one (12-month)
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
Study officials:
affiliation: Cardiovascular Research Center Aalst
name: Tom De Potter, MD
role: PRINCIPAL_INVESTIGATOR
References: