Clinical trial NCT04447300: Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.
Official title: Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Keywords: Atrial fibrillation ablation - unipolar signal modification
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[5\].

Eligibility criteria: 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.

Primary outcomes:
measure: Ablation success at 6-month after the index procedure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kottmaier M, Popa M, Bourier F, Reents T, Cifuentes J, Semmler V, Telishevska M, Otgonbayar U, Koch-Buttner K, Lennerz C, Bartkowiak M, Kornmayer M, Rousseva E, Brkic A, Grebmer C, Kolb C, Hessling G, Deisenhofer I. Safety and outcome of very high-power short-duration ablation using 70 W for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Europace. 2020 Mar 1;22(3):388-393. doi: 10.1093/europace/euz342.