Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter (COLLABORATE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter

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 [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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Alexandre Almorad, MD; Phone Number: +32 2 4776009; Email: alexandre.almorad@uzbrussel.be

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Recruiting
    • UZ Brussel Heart Rhythm Management Center
    • Contact: Carlo de Asmundis, MD, PhD; Phone Number: +32024763704; Email: hrmc@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing a first-time pulmonary vein isolation with the multielectrode radiofrequency balloon catheter (HELIOSTAR, Biosense Webster, CA, USA) will be prospectively included.

Description

Inclusion Criteria:

• symptomatic atrial fibrillation with indication to catheter ablation

Exclusion Criteria:

• age <18 years old
• pregnancy
• any contraindications to catheter ablation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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)

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Radiofrequency, Ablation, Single-shot
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 1432022000278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No