Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351553
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-13
Brief Title:
Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation
Sponsor:
Hospital General Universitario de Alicante
Organization:
Hospital General Universitario de Alicante
Study Overview
Official Title:
Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation EASy-PULSE AF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
EASy-PULSE AF
Brief Summary:
Pulmonary vein PV isolation is considered the therapeutic strategy of choice to maintain sinus rhythm SR in symptomatic patients with atrial fibrillation AF The most commonly used energy modality is radiofrequency RF However this type of energy presents notable challenges such as its lack of selectivity for myocardial tissue which increases the risk of serious complications such as atrioesophageal fistula PV stenosis and vagus nerve injuries In this context PV isolation using pulsed field ablation PFA emerges as a promising alternative due to its greater myocardial selectivity However this selectivity presents additional challenges Preliminary studies indicate that PFA may not damage the autonomic nervous system ANS involved in the initiation and maintenance of AF in certain patients although stronger evidence is needed to support this claim
The investigators propose to carry out a single-center clinical trial although with the possibility in the future of including other centers Patients will be randomized to three research groups PV isolation with RF PV isolation with PFA and PV isolation combining PFA and RF using RF on the anterior wall and PFA on the posterior wall This assignment will be open to the operator who performs the procedure but blind for the researcher responsible for monitoring and for the data analyst The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA
The investigators propose to carry out a single-center clinical trial although with the possibility in the future of including other centers Patients will be randomized to three research groups PV isolation with RF PV isolation with PFA and PV isolation combining PFA and RF using RF on the anterior wall and PFA on the posterior wall This assignment will be open to the operator who performs the procedure but blind for the researcher responsible for monitoring and for the data analyst The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None