Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-24-02-046139-RS01 | Other Identifier | Eudamed |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-only | Experimental | The PF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only PF energy |
|
| Hybrid (PF posterior/RF anterior) | Experimental | The Hybrid arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using both PF and RF energy |
|
| RF-only | Active Comparator | The RF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only RF energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-only PVI | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute HRV variation (PF-only vs. RF-only arm) | 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). | from enrolment to the day after the ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute HRV variation (Hybrid vs. RF-only arm) | 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) | from enrolment to the day after the ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute difference in biomarker release | 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 | Peri-procedural: from procedure start (after groin puncture) to its end (before sheaths removal) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Valeriano, MD | Contact | +34 697539354 | chiara.valeriano91@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tom De Potter, MD | Cardiovascular Research Center Aalst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Hospital | Recruiting | Aalst | Belgium | 9300 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hybrid PVI | Procedure | 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 |
|
| RF-only PVI | Procedure | 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 |
|
| Atrial arrhythmia recurrences and atrial fibrillation burden |
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) |
| from day 91 to day 365 post-ablation |
| Acute difference in resting Heart Rate (HR) | Acute difference in average resting HR (Δ HR: baseline/1-day after ablation) between the investigational arms compared to the control arm | from enrolment to the day after the ablation procedure |
| HRV variation across the follow-up period | It measures the HRV change at 3, 6 and 12 months after the ablation procedure to assess the durability of the vagal modulation | from the first follow-up (3-month) visit until the last one (12-month) |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided