Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
Study NCT ID:
NCT04290559
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2020-02-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
Sponsor:
Newmarket Electrophysiology Research Group Inc
Organization:
Study Overview
Official Title:
Long-term Monitoring After Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
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:
LEARN-AF
Brief Summary:
The primary objective of this study is to determine the atrial fibrillation burden reduction, or absolute atrial fibrillation burden, associated with improvement in quality of life in patients undergoing ablation of persistent atrial fibrillation.
Detailed Description:
Atrial fibrillation (AF) is associated with a higher risk of stroke, heart failure and deterioration in patients' quality of life and it also has great effect on health care resource utilization due to increasing morbidity and mortality. Catheter ablation has shown to improve patients' quality of life (QOL), even in those who undergo a repeat procedure, equalizing healthy population and lowering subsequent health care resource utilization.
Success rates are usually based on an endpoint of total elimination of AF, typically absence of any AF recurrence \>30 seconds. While this is a high standard for clinical trial reporting, it does not necessarily measure the "clinical" success, since many patients will experience significant reduction in their AF burden with accompanying improvement in their functional status despite having ongoing brief recurrences of AF.
This is a prospective non-randomized, single-arm, cohort study. 200 patients with persistent atrial fibrillation undergoing catheter ablation will be enroled. AF burden post procedure will be evaluated with continuous monitoring with an implantable loop recorder (ILR) to assess recurrences and AF burden. QOL will be measured using the CCS-SAF severity scale, SF-36 and AFEQT scales pre-ablation and at 12 and 24 months.
Success rates are usually based on an endpoint of total elimination of AF, typically absence of any AF recurrence \>30 seconds. While this is a high standard for clinical trial reporting, it does not necessarily measure the "clinical" success, since many patients will experience significant reduction in their AF burden with accompanying improvement in their functional status despite having ongoing brief recurrences of AF.
This is a prospective non-randomized, single-arm, cohort study. 200 patients with persistent atrial fibrillation undergoing catheter ablation will be enroled. AF burden post procedure will be evaluated with continuous monitoring with an implantable loop recorder (ILR) to assess recurrences and AF burden. QOL will be measured using the CCS-SAF severity scale, SF-36 and AFEQT scales pre-ablation and at 12 and 24 months.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: