Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654401
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm in Patients with Persistent Atrial Fibrillation Before Radio Frequency Pulmonary Vein Isolation
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The aim of this study is to evaluate benefits of electric cardioversion in the early and long-term postoperative period in patients after radiofrequency catheter isolation of pulmonary veins Parameters of the left atrium will be evaluated by transthoracic echocardiography and electroanatomic mapping Preservation of the sinus rhythm will be assessed by 24-hour electrocardiographic monitoring
The main question that is planned to be answered is
Does a reverse remodeling of the left atrium andor a decrease in the progression of the fibrosis zone occur after performing electrical cardioversion and before subsequent catheter ablation in patients with persistent and long-standing persistent atrial fibrillation AF Can performed electrical cardioversion serve as a predictor of AF freedom in this group of patients
Participants will undergo a follow-up examinations echocardiography ECG 24-hour ECG monitoring at the 3rd 6th and 12th months after catheter ablation Based on the results of these examinations the recurrence rate of AF will be estimated
Two groups of patients will include both persistent and long-standing persistent AF Experimental group will include patients who underwent electrical cardioversion before the intervention and active comparator group will include those patients who did not undergo it The experimental group will be subdivided into a persistent AF patients who were successfully cardioverted in sinus rhythm and persistent AF patients who failed to restore sinus rhythm during DC at the time of catheter ablation Analysis and comparison of subgroups will be performed
The main question that is planned to be answered is
Does a reverse remodeling of the left atrium andor a decrease in the progression of the fibrosis zone occur after performing electrical cardioversion and before subsequent catheter ablation in patients with persistent and long-standing persistent atrial fibrillation AF Can performed electrical cardioversion serve as a predictor of AF freedom in this group of patients
Participants will undergo a follow-up examinations echocardiography ECG 24-hour ECG monitoring at the 3rd 6th and 12th months after catheter ablation Based on the results of these examinations the recurrence rate of AF will be estimated
Two groups of patients will include both persistent and long-standing persistent AF Experimental group will include patients who underwent electrical cardioversion before the intervention and active comparator group will include those patients who did not undergo it The experimental group will be subdivided into a persistent AF patients who were successfully cardioverted in sinus rhythm and persistent AF patients who failed to restore sinus rhythm during DC at the time of catheter ablation Analysis and comparison of subgroups will be performed
Detailed Description:
None
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