The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.
The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. After MAGiC obtains European approval, the study will be amended and expanded to collect Post-Market Clinical Follow-up data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Robotic magnetic radiofrequency (RF) ablation catheter
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark
RECRUITINGVilniaus universiteto ligoninė Santaros klinikos
Vilnius, Lithuania
RECRUITINGAcute Performance
The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.
Time frame: hospital discharge - up to 7 days post procedure
Acute Safety
Freedom from major adverse events (MAE) related to MAGiC.
Time frame: hospital discharge - up to 7 days post procedure
Chronic Success
Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.
Time frame: 3 months, 6 months, 12 months
Safety Events
Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.
Time frame: 3 months, 6 months, 12 months
Onset of Procedure-related New Arrhythmia
Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.
Time frame: 3 months, 6 months, 12 months
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