Atrial Fibrillation Paroxysmal
Conditions
Keywords
Atrial fibrillation ablation - unipolar signal modification
Brief 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 \[4\].
Detailed description
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 \[4\]. The high-power short duration (HPSD) RF application applies to all RF energies delivered at more than 40 W \[5\]. Higher the power more is the resistive heating causing wider tissue injury \[5\]. The lesion size with HPSD is larger in width but lesser in depth compared to lower powers with longer duration \[5\]. In contrast, RF applications of lower power and longer duration result in larger dissipation of RF energies deep into the tissues due to conductive heating causing tissue destruction at greater depths \[6\]. Hence, there is a risk of collateral tissue damage \[5\]. HPSD ablation has been advocated as a means to minimize the risk of collateral organ damage as the lesions are smaller in depth. However, Maintaining a high power for a constant duration in the absence of a guide may not be the right strategy \[5\]. Unipolar waveform modification by complete elimination of the negative component may serve as a guide for HPSD ablation \[5\].
Interventions
PROCEDUREhigh 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.
PROCEDUREStandard power application
Standard power application
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Paroxysmal atrial fibrillation
Exclusion criteria
* Age\< 18 or \> 80 years old, * Atrium (LA) diameter \> 50 mm, * The presence of a mechanical mitral valve prosthesis, * Left ventricular ejection fraction \< 40%, * Abnormal thyroid function, * Contraindication to anticoagulant therapy, * Current malignancy, * Prior catheter or surgical AF ablation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ablation success at 6-month after the index procedure | 6 months | Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 48 Hours. |
Outcome results
None listed