Lesion Contiguity in Very High Power-short Duration Ablation

Atrial Fibrillation Clinical Trial

Official title:

Effect of Very High Power-short Duration Ablation on Lesion Contiguity in Pulmonary Vein Isolation as Assessed by Late Gadolinium Enhancement Cardiovascular Magnetic Resonance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05368610
• Other study ID #: QDOT-MRI
• Status: Recruiting
• Start date: March 10, 2022
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: University of Barcelona
• Contact: Till F. Althoff, M.D.
• Phone: +34932271778
• Email: althoff[@]clinic.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Spain	Hospital Clinic, University of Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ablation lesion contiguity as assessed by LGE-CMR	Proportion of the circumferential ablation line covered by LGE (%)	LGE-CMR at 3 months post-ablation