Atrial Fibrillation (AF), Paroxysmal AF
Conditions
Keywords
vagal modulation, ganglionated plexi, pulsed field, dual-energy focal ablation, paroxysmal atrial fibrillation, heart rate variability, pulmonary vein isolation
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.
Interventions
PROCEDUREPF-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
PROCEDUREHybrid 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
PROCEDURERF-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
Sponsors
Biosense Webster, Inc.
VZW Cardiovascular Research Center Aalst
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 (> 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute HRV variation (PF-only vs. RF-only arm) | from enrolment to the day after the ablation procedure | It is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the PF-only arm and the control arm (RF-only). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute HRV variation (Hybrid vs. RF-only arm) | from enrolment to the day after the ablation procedure | The secondary endpoint is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the Hybrid arm and the control arm (RF-only) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute difference in biomarker release | Peri-procedural: from procedure start (after groin puncture) to its end (before sheaths removal) | It measures the change in blood levels of the neuro-biomarker S100B (Δ S100B) and the cardiac injury biomarker Troponin (Δ Troponin), both measured before and immediately (\ 20 minutes) after the ablation |
| Atrial arrhythmia recurrences and atrial fibrillation burden | from day 91 to day 365 post-ablation | It measures any difference between the study arms in terms of AT/AF/AFL documented recurrences and AF burden during the effective evaluation period (Day 91-Day 365) |
| Acute difference in resting Heart Rate (HR) | from enrolment to the day after the ablation procedure | Acute difference in average resting HR (Δ HR: baseline/1-day after ablation) between the investigational arms compared to the control arm |
| HRV variation across the follow-up period | from the first follow-up (3-month) visit until the last one (12-month) | It measures the HRV change at 3, 6 and 12 months after the ablation procedure to assess the durability of the vagal modulation |
Countries
Belgium
Contacts
Primary ContactChiara Valeriano, MD
Outcome results
None listed