Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333327
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Multielectrode Radiofrequency Balloon for Atrial Fibrillation Catheter Ablation A Multicenter Real-World Experience
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLLABORATE
Brief Summary:
All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter RFB Heliostar Biosense Webster will be included in a multicenter observational registry The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting
Detailed Description:
All consecutive atrial fibrillation patients undergoing pulmonary vein isolation PVI with the novel radiofrequency balloon catheter RFB Heliostar Biosense Webster will be prospectively included in a multicenter observational registry
PVI with the RFB will be performed as previously described Briefly after optimal RFB positioning confirmed through the correct alignment between the RFB and the pulmonary vein and sufficient electrode-tissue contact ablation is performed in temperature-controlled mode with unipolar radiofrequency energy Typically 2 posterior electrodes are identified on the RFB The power setting is 15 W and the target electrode temperature is 55 C The same energy is simultaneously delivered to all electrodes with a duration of 15-20 s for the posterior and 45-60 s for the non-posterior electrodes During ablation pulmonary vein potentials are monitored on the circular diagnostic catheter to evaluate real-time isolation In the case of pulmonary vein acute reconnection additional applications are delivered to achieve durable PVI An esophageal temperature probe will be used to monitor any increase in esophageal temperature
Follow-up will be performed according to each standard institutional protocol
Safety endpoints include any major periprocedural complications eg death atrioesophageal fistula stroketransient ischaemic attack pericardial effusiontamponade withwithout surgical treatment myocardial infarction and persistent phrenic palsy occurring within 7 days post-procedure except for atrioesophageal fistula Minor complications will also be reported including vascular access complications requiring treatment pericarditis and transient phrenic palsy
Efficacy outcome is defined as arrhythmia-free survival during the follow-up Arrhythmia recurrence is defined as any atrial tachyarrhythmias 30 s after a 90-day post-ablation blanking period
PVI with the RFB will be performed as previously described Briefly after optimal RFB positioning confirmed through the correct alignment between the RFB and the pulmonary vein and sufficient electrode-tissue contact ablation is performed in temperature-controlled mode with unipolar radiofrequency energy Typically 2 posterior electrodes are identified on the RFB The power setting is 15 W and the target electrode temperature is 55 C The same energy is simultaneously delivered to all electrodes with a duration of 15-20 s for the posterior and 45-60 s for the non-posterior electrodes During ablation pulmonary vein potentials are monitored on the circular diagnostic catheter to evaluate real-time isolation In the case of pulmonary vein acute reconnection additional applications are delivered to achieve durable PVI An esophageal temperature probe will be used to monitor any increase in esophageal temperature
Follow-up will be performed according to each standard institutional protocol
Safety endpoints include any major periprocedural complications eg death atrioesophageal fistula stroketransient ischaemic attack pericardial effusiontamponade withwithout surgical treatment myocardial infarction and persistent phrenic palsy occurring within 7 days post-procedure except for atrioesophageal fistula Minor complications will also be reported including vascular access complications requiring treatment pericarditis and transient phrenic palsy
Efficacy outcome is defined as arrhythmia-free survival during the follow-up Arrhythmia recurrence is defined as any atrial tachyarrhythmias 30 s after a 90-day post-ablation blanking period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None