Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator
NCT06156644 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-01-03
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.
Conditions
Interventions
- DEVICE
-
PFA
Ablation to treat trail fibrillation
Sponsors & Collaborators
-
University Hospital Freiburg
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2025-12-01
- Completion
- 2026-12-01
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