Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364215
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-08
Brief Title:
Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SMILE-AF
Brief Summary:
The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation PVI alone versus PVI with left atrial LA posterior wall isolation PWI using pulsed-field ablation PFA in the treatment of patients with paroxysmal atrial fibrillation PAF
Detailed Description:
This is an investigator-initiated prospective randomized multi-center Investigational Device Exemption IDE study Subjects undergoing first-time ablation for paroxysmal atrial fibrillation will be randomized to receive either pulmonary vein isolation PVI alone or PVI combined with posterior wall isolation PWI using pulsed field ablation PFA with the FARAWAVE PFA catheter
Following the index procedure all participants will enter a 3-month blanking period during which they will be closely monitored After this period anti-arrhythmic drug AAD therapy will be discontinued for all patients Throughout the entire study patients will be monitored using an implantable loop recorder ILR to assess the primary outcome of efficacy
The study includes a 12-month follow-up period and the primary objective is to assess and compare the efficacy defined as an improvement in freedom from all-atrial arrhythmias and safety defined as the occurrence of all procedure-related complications
Following the index procedure all participants will enter a 3-month blanking period during which they will be closely monitored After this period anti-arrhythmic drug AAD therapy will be discontinued for all patients Throughout the entire study patients will be monitored using an implantable loop recorder ILR to assess the primary outcome of efficacy
The study includes a 12-month follow-up period and the primary objective is to assess and compare the efficacy defined as an improvement in freedom from all-atrial arrhythmias and safety defined as the occurrence of all procedure-related complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None