The safety and efficacy of using shorter ablation times during pulmonary vein isolation using a multielectrode radiofrequency balloon catheter

Not Applicable

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN72715606
• Lead Sponsor: niversity Hospitals Sussex NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-19
• Last Update Posted: 8 January 2024
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Symptomatic paroxysmal or persistent atrial fibrillation
2. Suitable for clinically indicated catheter ablation
3. Aged > 18 years
4. Patients must be willing and able to provide informed consent
5. Patients must be willing and able to comply with peri-ablation and follow-up requirements

Exclusion Criteria

1. Pregnancy or planning pregnancy
2. Current enrollment in another interventional trial
3. Previous ablation for atrial fibrillation
4. Previous cardiac surgery
5. LA diameter > 55 mm in TTE
6. Patients with contraindications to systemic anticoagulation
7. Congenital heart disease
8. Body Mass Index > 40
9. Longstanding persistent atrial fibrillation (> 1 year)

Intraprocedural criteria:
Patients not tolerating insertion of the oesophageal temperature probe

Postprocedural criteria:
Patients not completing oesophageal endoscopy within 7 days of the ablation procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of acute Pulmonary Vein Isolation (PVI), defined as entrance block in all treated Pulmonary Veins measured using electronic case report form (eCRF) during the procedure