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Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.

NCT04447300 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-13

No results posted yet for this study

Summary

Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) \[1\]. However, the incidence of atrial fibrillation (AF) recurrence remains high \[2\], mostly due to pulmonary vein (PV) reconnection \[1\], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines \[3\].

Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions \[4\].

Conditions

  • Atrial Fibrillation Paroxysmal

Interventions

PROCEDURE

high power application

Radiofrequency delivery was performed in a point-by point fashion and continuously (an inter-lesion distance of 6 mm) with 50 W and 70 W and the ablation time for each point is limited to 7s and repeated if needed till the Unipolar signal modification turn to complete positive R wave.

PROCEDURE

Standard power application

Standard power application

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2022-10-01
Completion
2023-03-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447300 on ClinicalTrials.gov