Quantitative Ablation of Pulmonary Vein Vestibule in Paroxysmal Atrial Fibrillation.

Atrial Fibrillation Clinical Trial

— AI-ablation  

Official title:

A Prospective,Single Center, Randomized Controlled Trial of Quantitative Ablation of Pulmonary Vein Vestibule in Patients With Paroxysmal Atrial Fibrillation..

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04549714
• Other study ID #: AI-ablation
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2020
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: zhiyu Ling, MD
• Phone: 0086-13512362075
• Email: lingzy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, single-center, randomized controlled trial. In this part,a 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male and non-pregnant female subjects, 18=age=80.

2. Receiving or able to tolerate anticoagulant therapy.

3. Diagnosis of atrial fibrillation using an electrocardiogram or a dynamic electrocardiogram

4. The longest duration of atrial fibrillation episode is less than 7 days

5. Patient is compliant and willing to complete clinical follow-up.

Exclusion Criteria:

1. Patients who have previously undergone catheter ablation of atrial fibrillation;

2. Left ventricular ejection fraction <35%;

3. Pregnancy, planned pregnancy or lactating women;

4. Left atrial appendage thrombosis was detected by transesophageal ultrasound or intracardiac ultrasound;

5. Abnormal blood system or liver and kidney function;

6. Combined with severe organic heart disease (including congenital heart disease, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, and patients with myocardial infarction or coronary artery bypass grafting);

7. Patients who are considered unsuitable for inclusion by the investigator.

Related Conditions & MeSH terms

• Arrythmia
• Atrial Fibrillation

Intervention

Procedure:
• High AI in paroxysmal atrial fibrillation
Patients with paroxysmal AF will receive pulmonary vein vestibule ablation with high AI value, the AI target value for the front wall and the top wall is 550, and the rear wall and the lower wall are 400.
• Middle AI in paroxysmal atrial fibrillation
Patients with paroxysmal AF will receive pulmonary vein vestibule ablation with middle AI value, the AI target value for the front wall and the top wall is 500, and the rear wall and the lower wall are 350.
• Low AI in paroxysmal atrial fibrillation
Patients with paroxysmal AF will receive pulmonary vein vestibule ablation with low AI value, the AI target value for the front wall and the top wall is 450, and the rear wall and the lower wall are 300.

Locations

Country	Name	City	State
China	The Second Affilliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Yuehui Yin

Country where clinical trial is conducted

China, 

References & Publications (4)

Beinart R, Abbara S, Blum A, Ferencik M, Heist K, Ruskin J, Mansour M. Left atrial wall thickness variability measured by CT scans in patients undergoing pulmonary vein isolation. J Cardiovasc Electrophysiol. 2011 Nov;22(11):1232-6. doi: 10.1111/j.1540-8167.2011.02100.x. Epub 2011 May 26. — View Citation

Hussein A, Das M, Chaturvedi V, Asfour IK, Daryanani N, Morgan M, Ronayne C, Shaw M, Snowdon R, Gupta D. Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2017 Sep;28(9):1037-1047. doi: 10.1111/jce.13281. Epub 2017 Jul 26. — View Citation

Nakagawa H, Ikeda A, Govari A, et al.Prospective study using a new formula incorporating contact force, radiofrequency power and application time (Force-Power-Time Index) for quantifying lesion formation to guide long continuous atrial lesions in the beating canine heart. Circulation2013; 128:A12104.

Taghji P, El Haddad M, Phlips T, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation: A Pilot Study. JACC Clin Electrophysiol. 2018 Jan;4(1):99-108. doi: 10.1016/j.jacep.2017.06.023. Epub 2017 Sep 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of the pulmonary vein single-circle isolation.	Success rate of the pulmonary vein single-circle isolation.	Immediately after ablation
Secondary	Total procedure time.	Time from the start to the end of the ablation procedure	Immediately after ablation
Secondary	Left atrial operation time.	Left atrial operation time.	Immediately after ablation
Secondary	The location and number of supplemental ablation.	The number and location of the supplemental ablation required for pulmonary vein isolation after single-circle ablation	Immediately after ablation
Secondary	Intraoperative and postoperative stroke rates.	Intraoperative and postoperative stroke rates.	From the start of procedure to 7 days after ablation
Secondary	Intraoperative and postoperative pericardial tamponade rates.	Intraoperative and postoperative pericardial tamponade rates.	From the start of procedure to 7 days after ablation
Secondary	Number of steam pop during ablation.	Number of steam pop during ablation.	Immediately after ablation
Secondary	the proportion of sinus rhythm within 1 year	Proportion of patients who successfully maintained sinus rhythm within 1 year after ablation.	1 year
Secondary	Recurrence rate of atrial fibrillation	Diagnostic criteria for recurrence of atrial fibrillation: a blank period of 3 months after surgery. After 3 months of ablation surgery, atrial fibrillation/atrial flutter/atrial tachycardia with a duration of more than 30 seconds on the ECG was considered to be a recurrence of atrial fibrillation.	1 year