Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator (PFA-Breisgau)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: PFA

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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PFA strategy; PFA will be performed based on a specific protocol	Device: PFA; Ablation to treat trail fibrillation

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

Collaborators and Investigators

• Sponsor: University Hospital Freiburg

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PFA-Breisgau

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No