The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.
* The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation. * In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of: * DiamondTemp Ablation Catheter o Unidirectional and Bidirectional models * DiamondTemp Catheter-to RFG Cable * DiamondTemp GenConnect Cable * DiamondTemp FASTR Generator with Footswitch * DiamondTemp Irrigation Pump * DiamondTemp Irrigation Tubing Set
Na Homolce
Prague, Czechia
Clnique du Tonkin
Lyon, France
CHRU de Nancy
Nancy, France
Clinique Pasteur
Toulouse, France
Freedom from a composite of serious adverse events (SAE)
Freedom from a composite of serious adverse events (SAE)
Time frame: 30 days
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
Time frame: 12 months
Freedom from a composite SAE
Freedom from a composite SAE
Time frame: 7 days
Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes
Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes
Time frame: 12 months
Rate of single procedure success
Rate of single procedure success
Time frame: 12 months
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