Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter

Atrial Fibrillation Clinical Trial

— COLLABORATE  

Official title:

Multielectrode Radiofrequency Balloon for Atrial Fibrillation Catheter Ablation: A Multicenter Real-World Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333327
• Other study ID #: 1432022000278
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 1, 2030

Study information

• Verified date: March 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: Alexandre Almorad, MD
• Phone: +32 2 4776009
• Email: alexandre.almorad[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 [e.g. death, atrioesophageal fistula, stroke/transient ischaemic attack, pericardial effusion/tamponade with/without 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• symptomatic atrial fibrillation with indication to catheter ablation

Exclusion Criteria:

• age <18 years old

• pregnancy

• any contraindications to catheter ablation

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter
Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter

Locations

Country	Name	City	State
Belgium	UZ Brussel Heart Rhythm Management Center	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial arrhythmia recurrence after ablation	The primary outcome endpoint 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.	After 3 months post-ablation.
Primary	Procedural safety	The primary safety endpoint included any major periprocedural complications [e.g. death, atrioesophageal fistula, stroke/transient ischaemic attack (TIA), pericardial effusion/tamponade with/without surgical treatment, myocardial infarction, and persistent phrenic palsy] occurring within 7 days post-procedure (except for atrioesophageal fistula). Minor complications, including vascular access complications requiring treatment, pericarditis, and transient phrenic palsy will also be assessed.	Up to 7 days post-procedure (except for atrioesophageal fistula or pulmonary vein stenosis)