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

NCT04447300 | Unknown

• 1 other identifier: atrial fibrillation ablation
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 \[4\].

Conditions

Atrial Fibrillation Paroxysmal

Keywords

Atrial fibrillation ablation - unipolar signal modification

Outcome Measures

Primary Outcomes (1)

• Ablation success at 6-month after the index procedure

  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.

  6 months

Study Arms (2)

Standard power application

ACTIVE COMPARATOR

Procedure: Standard power application

High power application

ACTIVE COMPARATOR

Procedure: high power application

Interventions

high power application 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.

High power application

Standard power application PROCEDURE

Standard power application

Standard power application

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal atrial fibrillation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 31872249 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of cardiovascular medicine

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: September 20, 2021
• Primary Completion: October 1, 2022
• Study Completion: March 20, 2023
• Last Updated: January 13, 2021

Record last verified: 2021-01