Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06156644 |
| Other study ID # |
PFA-Breisgau |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2025 |
| Est. completion date |
December 1, 2026 |
Study information
| Verified date |
December 2023 |
| Source |
University Hospital Freiburg |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
