Clinical trial NCT04549714: Quantitative Ablation of Pulmonary Vein Vestibule in Paroxysmal Atrial Fibrillation.
Official title: A Prospective,Single Center, Randomized Controlled Trial of Quantitative Ablation of Pulmonary Vein Vestibule in Patients With Paroxysmal Atrial Fibrillation..
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Arrythmia
Keywords: Atrial Fibrillation
Ablation index
Quantitative Ablation
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of the pulmonary vein single-circle isolation.
timeFrame: Immediately after ablation
Secondary outcomes:
measure: Total procedure time.
timeFrame: Immediately after ablation
measure: Left atrial operation time.
timeFrame: Immediately after ablation
measure: The location and number of supplemental ablation.
timeFrame: Immediately after ablation
measure: Intraoperative and postoperative stroke rates.
timeFrame: From the start of procedure to 7 days after ablation
measure: Intraoperative and postoperative pericardial tamponade rates.
timeFrame: From the start of procedure to 7 days after ablation
measure: Number of steam pop during ablation.
timeFrame: Immediately after ablation
measure: the proportion of sinus rhythm within 1 year
timeFrame: 1 year
measure: Recurrence rate of atrial fibrillation
timeFrame: 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affilliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
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.
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.
citation: 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.
citation: 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.