Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter

NCT06333327 | Recruiting

• 1 other identifier: 1432022000278
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Radiofrequency, Ablation, Single-shot

Outcome Measures

Primary Outcomes (2)

• 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)

Interventions

Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter DEVICE

Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• symptomatic atrial fibrillation with indication to catheter ablation

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel Heart Rhythm Management Center

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandre Almorad, MD

CONTACT

+32 2 4776009; alexandre.almorad@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: January 1, 2021
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

BE (1)