Pulse-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator

Study Overview
=================
Brief Summary
-----------------
In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. For 12 months and follow-up for 12 months, after a 3-months blanking period 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled.

Detailed Description
-----------------
The principal safety and efficacy of PFA have been established in previous studies, showing low compli¬cation rates, short procedure times, and non-inferior/ superior efficiency compared to thermal abla¬tion.18, 19 However, current generators available for clinical practice are not generally designed to allow both non-thermal and thermal ablation in single shot settings. Moreover, modification of PFA sequences is not supported in commercially available systems. Flexible, multi-modal generators that allow one to conduct PFA or RF ablation using one and the same catheter would be highly desirable, from a clinical point of view, to allow for on-the-fly decision-making in view of individual patient requirements. In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. This generator will be CE marked in Q3/24. Upon completion of the ethical approval process in Q2/25, the 'first in human' study, exploring safety of the Stockert PFA generator will be started. The trial will be a prospective single arm study at the UHZ Freiburg · Bad Krozingen and will recruit for 12 months and follow-up for 12 months, after a 3-months blanking period. 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled. Exclusion criteria will be age <18 years, previous left atrial ablation, and lack or withdrawal of written informed consent. Data acquisition will use an electronic case report form (RedCap Database). Procedures will be performed using standard operating procedures (SOP). In short: ablations will be performed under deep analgo-sedation and/or general anaesthesia. Trans¬oesophageal echocardiography will be performed if patients present with either AF or atrial tachycardia (to exclude intracardiac thrombi) or in sinus rhythm (in patients with interrupted oral anticoagulation and CHA2DS2-VASc-Score ≥2). Atrial transseptal puncture will be performed for access to pulmonary veins (PV), using a fixed curve transseptal sheath and transseptal needle according to standard SOP. PFA catheters (FARAWAVE™, Boston Scientific) will be utilized, as in prior work with a commercial PFA system (FARAPULSE™, Boston Scientific) at the UHZ. At every PV antrum, 8 PFA-pulses will be delivered in 'flower' and 'basket' configurations (delivery of additional PFA-pulses will be at operator's discretion).

Official Title
-----------------
Pulse-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: PFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new onset atrial fibrillation Exclusion Criteria: age <18 years previous left atrial ablation lack or withdrawal of written informed consent unable to receive ablation therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single Arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PFA strategy<br>PFA will be performed based on a specific protocol | Device: PFA<br>* Ablation to treat trail fibrillation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of death | Primary endpoints focusing of the safety of the strategy | 12 month |