Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523738
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Left Atrial Volume Changes Who Underwent Cardioversion and Recurrence of AF After RF Ablation in Persistent AF SAFE-AF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Association of Left Atrial Volume Changes After Cardioversion and Recurrence of Atrial Fibrillation After Radiofrequency Ablation in Patients With Persistent Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-07
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:
SAFE-AF-ABL
Brief Summary:
Electricalpharmacological cardioversion improves structural remodeling of left atrium We hypothesize that persistent atrial fibrillation AF patients with more significant left atrial size reduction after cardioversion have lower AF recurrence rates following radiofrequency ablation The aim is to evaluate the relationship between changes in left atrial size 3 to 6 months after cardioversion and the recurrence rate of atrial fibrillation following radiofrequency ablation
Detailed Description:
Background Atrial fibrillation AF is estimated to affect over 33 million people worldwide and is associated with significant co-morbidities such as embolic stroke heart failure dementia Consequently AF poses a significant burden to the healthcare system in both direct and indirect costs The management of AF is complex especially for patients with persistent AF which is defined as sustained AF for 7 days It is preferable to terminate the AF and restore normal sinus rhythm for relief of symptoms associated with AF or improvement of cardiac structure and function The maintenance of AF especially persistent AF is associated with fibrosis of left atria Furthermore AF itself promotes fibrosis which in turn leads to increased conduction heterogeneity within the atrial substrate resulting in further progression of AF In animal models alterations in myocytes after sustained AF resemble those of myocardial hibernation Ultimately these structural changes would lead to Calcium overload and metabolic stress similar changes have been observed in humans In humans atrial dilatation and degenerative changes have been observed Interstitial fibrosis is the prime cause of structural remodeling in left atrium In AF patients who did not experience AF recurrence after catheter ablation the reduction in left atrial size was more significant In the past a 15 reduction in left atrial volume has been defined as left atrial reverse remodeling and is associated with the maintenance of sinus rhythm after AF ablation It remains unclear whether the reduction in left atrial size after the restoration of sinus rhythm through electrical or pharmacological cardioversion in patients with persistent AF can predict AF recurrence following radiofrequency ablation
Objectives To evaluate the relationship between changes in left atrial size 3-6 months after electrical or pharmacological cardioversion in patients with persistent AF and AF recurrence within one year following radiofrequency ablation
Methods This study will be an observational trial of patients with persistent AF Candidates will be identified among inpatients or outpatients if they have had at least two echocardiograms one before and one 3-6 months after pharmacological or electrical cardioversion Heart rhythm will be assessed through medical records and telephone surveys
Objectives To evaluate the relationship between changes in left atrial size 3-6 months after electrical or pharmacological cardioversion in patients with persistent AF and AF recurrence within one year following radiofrequency ablation
Methods This study will be an observational trial of patients with persistent AF Candidates will be identified among inpatients or outpatients if they have had at least two echocardiograms one before and one 3-6 months after pharmacological or electrical cardioversion Heart rhythm will be assessed through medical records and telephone surveys
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