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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Freiburg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

new onset atrial fibrillation

Disqualifiers

age <18 years

previous left atrial ablation

lack or withdrawal of written informed consent

unable to receive ablation therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • PFA

    Device

    Ablation to treat trail fibrillation

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: PFA strategyOther 1 intervention

Trial outcomes

Primary outcomes

1

number of death

Primary endpoints focusing of the safety of the strategy

Time frame
12 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Freiburg

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: