The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Atrial flutter Ablation
OLV Hospital
Aalst, Belgium
St. Antonius Hospital
Nieuwegein, Netherlands
Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure.
Time frame: 30 DAYS
Acute Success measured by Percentage of subjects with termination of AFl and complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus at the end of the ablation procedure.
Time frame: 30 minutes
Outcome success
Percent of subjects with absence of AFl at 30 days (30 day ECG and as reported by subject or holter monitor)
Time frame: 30 days
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