Quantitative Ablation of Pulmonary Vein Vestibule in Paroxysmal Atrial Fibrillation. (AI-ablation)

September 14, 2020 updated by: Yuehui Yin

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: zhiyu Ling, MD
  • Phone Number: 0086-13512362075
  • Email: lingzy@163.com

Study Locations

    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • The Second Affilliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High AI in paroxysmal atrial fibrillation
In this group,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.
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.
EXPERIMENTAL: Middle AI in paroxysmal atrial fibrillation
In this group,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.
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.
EXPERIMENTAL: Low AI in paroxysmal atrial fibrillation
In this group,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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of the pulmonary vein single-circle isolation.
Time Frame: Immediately after ablation
Success rate of the pulmonary vein single-circle isolation.
Immediately after ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total procedure time.
Time Frame: Immediately after ablation
Time from the start to the end of the ablation procedure
Immediately after ablation
Left atrial operation time.
Time Frame: Immediately after ablation
Left atrial operation time.
Immediately after ablation
The location and number of supplemental ablation.
Time Frame: Immediately after ablation
The number and location of the supplemental ablation required for pulmonary vein isolation after single-circle ablation
Immediately after ablation
Intraoperative and postoperative stroke rates.
Time Frame: From the start of procedure to 7 days after ablation
Intraoperative and postoperative stroke rates.
From the start of procedure to 7 days after ablation
Intraoperative and postoperative pericardial tamponade rates.
Time Frame: From the start of procedure to 7 days after ablation
Intraoperative and postoperative pericardial tamponade rates.
From the start of procedure to 7 days after ablation
Number of steam pop during ablation.
Time Frame: Immediately after ablation
Number of steam pop during ablation.
Immediately after ablation
the proportion of sinus rhythm within 1 year
Time Frame: 1 year
Proportion of patients who successfully maintained sinus rhythm within 1 year after ablation.
1 year
Recurrence rate of atrial fibrillation
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 7, 2019

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

August 31, 2021

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

September 14, 2020

First Posted (ACTUAL)

September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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