Status:
NOT_YET_RECRUITING
Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator
Lead Sponsor:
University Hospital Freiburg
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 mo...
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 ab...
Eligibility Criteria
Inclusion
- new onset atrial fibrillation
Exclusion
- age \<18 years
- previous left atrial ablation
- lack or withdrawal of written informed consent
- unable to receive ablation therapy
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06156644
Start Date
July 1 2025
End Date
December 1 2026
Last Update
January 3 2024
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