Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415149
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2024-05-10
Brief Title:
High-Power Short-Duration Ablation in Treatment of Patients With Atrial Fibrillation
Sponsor:
Peoples Friendship University of Russia
Organization:
Peoples Friendship University of Russia
Study Overview
Official Title:
High-Power Short-Duration Ablation in Treatment of Patients With Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPSD
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 05 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 27 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 13C Consequently at 30 watts the temperature reaches 39C and at 50 watts it rises to 65C The formation of an irreversible lesion necessitates a temperature exceeding 50C 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
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 27 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 13C Consequently at 30 watts the temperature reaches 39C and at 50 watts it rises to 65C The formation of an irreversible lesion necessitates a temperature exceeding 50C 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
Detailed Description:
The research was a multi-center retrospective blind randomized controlled trial between 2021 and 2023 A comprehensive sample of 185 participants was enrolled in the study and categorized into 2 cohorts each of which was further subdivided into two subgroups Patients were enrolled in the study after providing informed consent In the first group n95 PVI was performed with power of 50 watts in Ia subgroup n55 AI was 400-450 arbitrary units au for the posterior wall and 500-550 au for the anterior wall in Ib n40 AI was 400-450 au for the posterior wall and 450-500 au for the anterior wall In the second group n90 PVI was performed at a power of 45 watts in IIa n50 with target AI of 400-450 au for the posterior wall and 500-550 au for the anterior wall in IIb n40 AI of 400-450 au for the posterior wall and 450-500 au for the anterior wall
Assessment of conduction block was performed 20 minutes after RFA using a twenty-pole diagnostic electrode Lasso Biosense Webster USA
Assessment of conduction block was performed 20 minutes after RFA using a twenty-pole diagnostic electrode Lasso Biosense Webster USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None