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 volunteersQualifiers
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
Single group
Treatments tested in this trial
PFA
DeviceAblation to treat trail fibrillation
Treatment groups
Trial outcomes
Primary outcomes
number of death
Primary endpoints focusing of the safety of the strategy
Locations
Sponsors and contacts
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University Hospital Freiburg
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: