Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516822
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation SINUS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation SINUS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SINUS
Brief Summary:
Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation AF As the cornerstone of catheter ablation for AF the safety and efficacy of circumferential pulmonary vein isolation CPVI have been confirmed However for persistent AF especially for long-standing persistent AF LSPAF the recurrence rate is still high Whether the ethanol infusion EI into the vein of Marshall EI-VOM and linear ablation could improve the success rate remains controversial
The SINUS study is a prospective multicenter randomized trial which is designed to compare the efficacy and safety between CPVI with modified linear ablation CPVI-MLA and CPVI only for the treatment of LSPAF
The SINUS study is a prospective multicenter randomized trial which is designed to compare the efficacy and safety between CPVI with modified linear ablation CPVI-MLA and CPVI only for the treatment of LSPAF
Detailed Description:
The SINUS study will include 320 patients with LSPAF undergoing catheter ablation for the first time All patients will be randomized to either the CPVI-MLA group or CPVI only group in a 11 ratio The CPVI-MLA strategy is a fixed ablation approach consisting of EI-VOM CPVI left atrial posterior wall isolation PWI linear ablation of mitral isthmus MI left atrial intima adjoining CS LAI-CS and cavo-tricuspid isthmus CTI and superior vena cava isolation SVCI The follow-up is for a minimum of 12 months with rhythm monitoring The primary endpoint is freedom from any documented atrial arrhythmia including atrial fibrillation AF atrial tachycardia AT or atrial flutter AFL 30 seconds after the initial 3 months blanking period without the use of antiarrhythmic drugs AADs at 12 months after the index ablation procedure
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