Ablation Catheter
DeviceAblation of paroxysmal atrial fibrillation
NCT Number: NCT03056222
The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Hartcentrum OLV Aalst, Aalst, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ablation of paroxysmal atrial fibrillation
Time frame: 12 months post procedure
Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure
Time frame: 30 minutes post procedure
Confirmation of electrical isolation with a circular mapping catheter
Time frame: During procedure
Time will be taken
Time frame: From procedure to 12 months post procedure
E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death
Time frame: 12 months post procedure
Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure
I-Med-Pro GmbH
Other
Acronym: CF²
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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