Lesion Contiguity in Very High Power-short Duration Ablation

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05368610

Enrollment

128

Registered

2022-05-10

Start date

2022-03-10

Completion date

2023-06-30

Last updated

2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Catheter ablation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Spain

Contacts

Primary ContactTill F. Althoff, M.D.

althoff@clinic.cat+34932271778

Backup ContactLluis Mont, M.D., Ph.D.

LMONT@clinic.cat+34932275551

Outcome results