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

NCT ID: NCT04447300

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2023-03-20

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].

Conditions

Atrial Fibrillation Paroxysmal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard power application

Group Type: ACTIVE_COMPARATOR

Standard power application

Intervention Type: PROCEDURE

Standard power application

High power application

Group Type: ACTIVE_COMPARATOR

high power application

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Standard power application

Standard power application

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Abdelrady Abdelsalam Farghaly

Assistant lecturer of cardiovascular medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 31872249 (View on PubMed)

Other Identifiers

atrial fibrillation ablation

Identifier Type: -

Identifier Source: org_study_id