Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator
PFA-Breisgau
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Jul 2025
Shorter than P25 for not_applicable atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 3, 2024
December 1, 2023
5 months
November 13, 2023
December 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
number of death
Primary endpoints focusing of the safety of the strategy
12 month
Study Arms (1)
PFA strategy
OTHERPFA will be performed based on a specific protocol
Interventions
Eligibility Criteria
You may qualify if:
- new onset atrial fibrillation
You may not qualify if:
- age \<18 years
- previous left atrial ablation
- lack or withdrawal of written informed consent
- unable to receive ablation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
November 13, 2023
First Posted
December 5, 2023
Study Start
July 1, 2025
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
January 3, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share