Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578793
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Comparison of Catheter Plus Marshall Vein Ablation vs Catheter Ablation Alone in Persistent AF With Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Catheter Ablation Combined With Ethanol Ablation of the Marshall Vein vs Catheter Ablation Alone in Persistent Atrial Fibrillation With Heart Failure A Multicenter Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This multicenter randomized controlled trial aims to compare the clinical efficacy and safety of combining catheter ablation with Marshall vein ethanol ablation versus catheter ablation alone in patients with persistent atrial fibrillation AF and concomitant heart failure Persistent AF is a common arrhythmia that significantly impacts the quality of life and survival rates especially when coexisting with heart failure While catheter ablation is a standard treatment for AF its effectiveness in persistent AF particularly in patients with heart failure remains suboptimal The addition of Marshall vein ethanol ablation may enhance treatment outcomes by targeting arrhythmogenic substrates This study will enroll 120 participants across three centers to evaluate whether this combined approach can reduce AF recurrence improve heart function and enhance patient outcomes compared to catheter ablation alone
Detailed Description:
Persistent atrial fibrillation AF combined with heart failure presents a significant clinical challenge due to the high rates of morbidity and mortality associated with these conditions Catheter ablation is widely used to manage AF but its efficacy in persistent AF particularly in patients with heart failure is limited Recent advances suggest that targeting the Marshall vein with ethanol ablation may offer additional benefits by disrupting critical pathways involved in AF maintenance
This study is designed to evaluate the efficacy of combining Marshall vein ethanol ablation with standard catheter ablation compared to catheter ablation alone in a well-defined patient population Conducted across three centers this randomized controlled trial will rigorously assess whether the combined approach can offer superior outcomes including lower AF recurrence rates and improved heart function The studys findings are expected to contribute valuable insights into optimizing treatment strategies for this high-risk patient group
This study is designed to evaluate the efficacy of combining Marshall vein ethanol ablation with standard catheter ablation compared to catheter ablation alone in a well-defined patient population Conducted across three centers this randomized controlled trial will rigorously assess whether the combined approach can offer superior outcomes including lower AF recurrence rates and improved heart function The studys findings are expected to contribute valuable insights into optimizing treatment strategies for this high-risk patient group
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