Lesion Contiguity in Very High Power-short Duration Ablation

• Conditions: Atrial Fibrillation

• Registration Number: NCT05368610
• Lead Sponsor: University of Barcelona

Brief Summary

This observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR). Patients with paroxysmal or early persistent atrial fibrillation (AF) scheduled for pulmonary vein isolation (PVI) undergo point-by-point ablation using the QDOT micro catheter applying Qmode+ (90W over 4 seconds). All patients receive an LGE-CMR 3 months after the procedure for ablation lesion assessment. Contiguity of LGE-CMR-detected ablation lesions will be compared with a matched control group of patients that have undergone PVI accomplished by ablation index-guided ablation with 40 W following the CLOSE protocol.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Status Verified: 2022-05
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Last Update Submitted: 2022-05-05
• Study First Posted: 2022-05-10
• Last Update Posted: 2022-05-10
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• paroxysmal or early persistent (max. 3 months) atrial fibrillation
• scheduled for PVI-only catheter ablation

Exclusion Criteria

• long-standing persistent atrial fibrillation
• previous left atrial ablation
• claustrophobia preventing CMR
• sever renal insufficiency (GFR >30 ml/min)
• gadolinium contrast allergy
• presence of implantable devices not compatible with magnetic resonance
• pregnancy and lactation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ablation lesion contiguity as assessed by LGE-CMR	LGE-CMR at 3 months post-ablation	Proportion of the circumferential ablation line covered by LGE (%)

Trial Locations

Locations (1)

Hospital Clinic, University of Barcelona; 🇪🇸 Barcelona, Catalonia, Spain