Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647485
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulse Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GPfIRE
Brief Summary:
The objective of this clinical trial is to evaluate the impact of pulse field PF energy both alone and in combination with radiofrequency RF energy on vagal modulation during point-by-point pulmonary vein isolation PVI in patients with paroxysmal atrial fibrillation PAF The effect of PF energy on ganglionated plexi GP will be assessed using heart rate variability HRV as a surrogate marker Participants will be randomized into three groups the PF-only group and the Hybrid group PF posteriorRF anterior as the experimental arms and the RF-only group as the control arm HRV will be measured before and 24 hours after the PVI procedure Additionally cardio and neuro biomarkers Troponin and S100B will be measured pre-procedure and 20 minutes post-ablation All participants will be followed for 12 months with 24-hour Holter-ECG evaluations scheduled at 3 6 and 12 months after the initial ablation procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None