Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04549714
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2019-06-07
Brief Title:
Quantitative Ablation of Pulmonary Vein Vestibule in Paroxysmal Atrial Fibrillation
Sponsor:
Yuehui Yin
Organization:
The Second Affiliated Hospital of Chongqing Medical University
Study Overview
Official Title:
A ProspectiveSingle Center Randomized Controlled Trial of Quantitative Ablation of Pulmonary Vein Vestibule in Patients With Paroxysmal Atrial Fibrillation
Status:
UNKNOWN
Status Verified Date:
2020-09
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:
AI-ablation
Brief Summary:
The purpose of this trial is to explore the optimal AI value for isolating the pulmonary veins and achieving left ventricular apex and mitral isthmus block Patients with atrial fibrillation who are scheduled to undergo catheter ablation will be randomized to different groups then every group receive circumferential pulmonary vein isolation with different AI values The relevant indicators such as the proportion of pulmonary vein single-circle isolation operation time the incidence of complications and the proportion of recurrence of atrial fibrillation and other atrial arrhythmias after 1 year were collected
Detailed Description:
This is a prospective single-center randomized controlled trial In this parta total of 90 patients with paroxysmal atrial fibrillation who are scheduled for catheter ablation were randomly divided into 3 groups 30 patients in each group For the first group the AI target value for the front wall and the top wall is 550 and the rear wall and the lower wall are 400 For the second group the AI target values for the front wall and the top wall are 500 the rear wall and the lower wall are 350 For the third group the AI target values for the front wall and top wall are 450 the rear wall and the lower wall are 300 The pressure value at each point is 5-15 g and the distance between adjacent ablation points is less than 5 mm The relevant indicators such as single-circle isolation rate of the pulmonary vein operation time the left atrial operation time and the supplemental ablation site are recoded The incidence of intraoperative and postoperative complications such as stroke pericardial tamponade and steam pop during ablation are observed Dynamic electrocardiography is performed during the follow-up period to evaluate the proportion of sinus rhythm within 1 year
Study Oversight
Has Oversight DMC:
None
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?:
None