High-Power, Short-Duration Ablation in Treatment of Patients With Atrial Fibrillation

NCT06415149 | Completed

• 1 other identifier: 27711
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) stands as the most common type of cardiac arrhythmia. The frequency of AF in the overall population is 1-2%, with the incidence rate increasing with age from 0.5% in the 40-50 years old to 5-15% in those aged 80. \[According to current recommendations for catheter ablation (CA) in patients with AF, the isolation of the pulmonary veins (PV) is a pivotal aspect of treating this arrhythmia. Despite recent advancements, 20-45% of patients experience recurrences after PV isolation. According to the study by Wasmer K. et al., it was demonstrated that most patients with recurrent AF after PVI showed at least one reconnected vein during redo procedures. The primary cause of recurrences is the restoration of conduction, attributed to endurable isolation (non-transmural, intermittent RF). Numerous approaches have been presented to enhance the outcomes of surgical treatment for AF, such as the CLOSE protocol and Ablation Index (AI) . CLOSE protocol represents an approach aimed at isolating the PV ostia through precise continuous (distance between points ≤ 6 mm) radiofrequency intervention, achieving target ablation index values of ≥ 400au for the posterior wall and ≥ 500au for the anterior wall. The Ablation Index is a marker of quality lesion formation, providing a visual representation of the lesion based on the integration of power, contact force, and time parameters, which is displayed on the CARTO® 3 system (Biosense Webster). Throughout radiofrequency ablation, electromagnetic energy undergoes conversion into thermal energy, leading to tissue damage and temperature elevation. The temperature elevation process encompasses two stages: resistive heating, impacting surface tissues (1-2mm), and conductive heating, which facilitates the transfer of heat from surface tissues to underlying tissues. In the presence of good catheter-endocardium contact (25%), only 9% of the power is effectively delivered to the endocardium. For instance, at a power level of 30 watts and optimal contact (25%) with the endocardium, merely 2.7 watts are transferred to the endocardial tissue. When applying 30 watts of power for 30 seconds, a total energy delivery of 900 joules occurs, with only 90 joules being imparted to the endocardium. Similarly, at 50 watts for 10 seconds, only 45 joules of energy are transmitted to the endocardium. When operating at 10 watts, the catheter temperature elevates by 13°C. Consequently, at 30 watts, the temperature reaches 39°C, and at 50 watts, it rises to 65°C. The formation of an irreversible lesion necessitates a temperature exceeding 50°C. During standard radiofrequency ablation (RFA) procedures with power settings ranging from 20 to 45 watts and a duration of 20 to 60 seconds, the formation of ablation points predominantly occurs during the conductive heating phase. High power short duration ablation (HPSD) is an approach that reduces the conductive heating phase while increasing the resistive heating phase. This results in an expanded area of lesion, facilitating the formation of transmural lesions in the atrial myocardium with irreversible tissue damage and reduced risk to surrounding structures, such as thermal injury to the esophagus. The strategy of HPSD ablation was developed to overcome limitations of the traditional approach. However, much remains unknown regarding the safety and effectiveness of this approach. Additionally, the question for the optimal interventional treatment method for atrial fibrillation (AF) and the selection of the optimal RF energy for pulmonary vein isolation still require confirmation. This forms the basis for our research objective.

Conditions

Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Keywords

high-power, short-duration; catheter ablation

Outcome Measures

Primary Outcomes (2)

• Interoperative outcomes

  1-Radiofrequency (RF) ablation duration from start of first pulmonary vein isolation to end of 2-the last lesion. 3-Total Procedure duration. 4-First pass PVI. 5-Interoperative complications. 6-Total RF energy delivery. 7-Number of RF lesions required for PVI. 8-Freedom from Atrial Fibrillation.

  During ablation

• Blinded period

  1. The proportion of patients maintaining Freedom from Atrial Fibrillation. 2. Overall Complication rate.

  1- 3 months after ablation

Secondary Outcomes (1)

• Long-term outcomes

  6 -12 months

Study Arms (2)

High power short duration ablation with 50 W

EXPERIMENTAL

Group 1 (n=95): pulmonary vein isolation for treatment of atrial fibrillation was performed with power of 50 watts in Ia subgroup (n=55) AI (ablation index) was 400-450 arbitrary units (au) for the posterior wall and 500-550 au for the anterior wall, in Ib (n=40) AI was 400-450 au for the posterior wall and 450-500 au for the anterior wall.

Procedure: High power short duration ablation with 50 W

High power short duration ablation with 45 W

EXPERIMENTAL

Group 2 (n=90): Pulmonary vein islolation was performed at a power of 45 watts, in IIa subgroup (n=50) with target AI of 400-450 au for the posterior wall and 500-550 au for the anterior wall in IIb (n=40) AI of 400-450 au for the posterior wall and 450-500 au for the anterior wall.

Procedure: High power short duration ablation with 45 W

Interventions

High power short duration ablation with 50 W PROCEDURE

Group 1 (n=95): pulmonary vein isolation for treatment of atrial fibrillation was performed with power of 50 watts in Ia subgroup (n=55) AI (ablation index) was 400-450 arbitrary units (au) for the posterior wall and 500-550 au for the anterior wall, in Ib (n=40) AI was 400-450 au for the posterior wall and 450-500 au for the anterior wall.

High power short duration ablation with 50 W

High power short duration ablation with 45 W PROCEDURE

Group 2 (n=90): Pulmonary vein islolation was performed at a power of 45 watts, in IIa subgroup (n=50) with target AI of 400-450 au for the posterior wall and 500-550 au for the anterior wall in IIb (n=40) AI of 400-450 au for the posterior wall and 450-500 au for the anterior wall.

High power short duration ablation with 45 W

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic atrial fibrillation (AF) or resistance to at least one antiarrhythmic drug from the first or third group of antiarrhythmic drugs.

You may not qualify if:

• Left atrial thrombosis
• significant coronary artery disease requiring revascularization
• valvular heart disease requiring surgical correction
• acute infectious diseases
• severe heart failure (NYHA class IV) or left ventricular ejection fraction (LVEF) \<35%,
• history of stroke within the past 3 months.

Sponsors & Collaborators

• People's Friendship University of Russia: lead
• City Clinical Hospital No.1 named after N.I. Pirogov: collaborator

Study Sites (1)

People's friendship university of Russia

Moscow, 117198, Russia

Location

Related Publications (1)

• Fayez A. , Safonov N. V., Steklov A. S., Faybushevich A. G., Baranovich V. Y. HIGH POWER SHORT DURATION ABLATION USING ABLATION INDEX (AI) IN PATIENTS WITH ATRIAL FIBRILATION // Современная наука: актуальные проблемы теории и практики. Серия: Естественные и Технические Науки. -2023. -№02. -С. 244-250 DOI 10.37882/2223-2966.2023.02.37

  BACKGROUND

Related Links

• Related Info

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)