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

NCT ID: NCT06156644

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-01

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).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PFA strategy

PFA will be performed based on a specific protocol

Group Type: OTHER

PFA

Intervention Type: DEVICE

Ablation to treat trail fibrillation

Interventions

PFA

Ablation to treat trail fibrillation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Dirk Westermann

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PFA-Breisgau

Identifier Type: -

Identifier Source: org_study_id