- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549714
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
Status
Unknown
Conditions
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:
- Male and non-pregnant female subjects, 18≤age≤80.
- Receiving or able to tolerate anticoagulant therapy.
- Diagnosis of atrial fibrillation using an electrocardiogram or a dynamic electrocardiogram
- The longest duration of atrial fibrillation episode is less than 7 days
- Patient is compliant and willing to complete clinical follow-up.
Exclusion Criteria:
- Patients who have previously undergone catheter ablation of atrial fibrillation;
- Left ventricular ejection fraction <35%;
- Pregnancy, planned pregnancy or lactating women;
- Left atrial appendage thrombosis was detected by transesophageal ultrasound or intracardiac ultrasound;
- Abnormal blood system or liver and kidney function;
- 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);
- 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.
General Publications
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-ablation
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.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
Beijing Anzhen HospitalJohnson & Johnson; Heart Health Research CenterNot yet recruitingParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
-
Maastricht UniversityRadboud University Medical Center; Maastricht University Medical CenterRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Atrial Fibrillation ParoxysmalNetherlands
Clinical Trials on High AI in paroxysmal atrial fibrillation
-
Farapulse, Inc.CompletedParoxysmal Atrial FibrillationCroatia
-
Abbott Medical DevicesCompletedParoxysmal Atrial FibrillationUnited States
-
C. R. BardCompletedParoxysmal Atrial FibrillationCanada, Germany, United Kingdom
-
Ziekenhuis Oost-LimburgRecruiting
-
University of Split, School of MedicineRecruitingRecurrence | Atrial Fibrillation ParoxysmalCroatia
-
Russian Academy of Medical SciencesDr. Falk Pharma GmbHCompletedGastroesophageal Reflux DiseaseRussian Federation
-
Yonsei UniversityCompletedObesity | Diabetes Mellitus | OverweightKorea, Republic of
-
Indiana UniversityUniversity of California, Los Angeles; Topera, MedicalTerminatedParoxysmal Atrial FibrillationUnited States
-
Hungkuang UniversityNot yet recruitingSchizophrenia | Constipation | PsylliumTaiwan
-
Montreal Heart InstituteCompletedAtrial Fibrillation | Congestive Heart FailureCanada