Atrial FibrillationAI-ablationNCT04549714
Quantitative Ablation of Pulmonary Vein Vestibule in Paroxysmal Atrial Fibrillation.
A study testing High AI in paroxysmal atrial fibrillation, Middle AI in paroxysmal atrial fibrillation and Low AI in paroxysmal atrial fibrillation in people with Atrial Fibrillation and Arrythmia, run by Yuehui Yin at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Arrythmia
- What is being tested?
- High AI in paroxysmal atrial fibrillation, Middle AI in paroxysmal atrial fibrillation and Low AI in paroxysmal atrial fibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affilliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
ZHIYU LING, MD, +8613512362075, lingzy1977@163.com
YANPING XU, MD, +8613618273302, yxu2013@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Arrythmia
- Being tested
- High AI in paroxysmal atrial fibrillation, Middle AI in paroxysmal atrial fibrillation, Low AI in paroxysmal atrial fibrillation
- Keywords
- Atrial Fibrillation, Ablation index, Quantitative Ablation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High AI in paroxysmal atrial fibrillationProcedure or surgery
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 fibrillationProcedure or surgery
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 fibrillationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| High AI in paroxysmal atrial fibrillation | Experimental | 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. Receives: Procedure: High AI in paroxysmal atrial fibrillation |
| Middle AI in paroxysmal atrial fibrillation | Experimental | 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. Receives: Procedure: Middle AI in paroxysmal atrial fibrillation |
| Low AI in paroxysmal atrial fibrillation | Experimental | 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. Receives: Procedure: Low AI in paroxysmal atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the pulmonary vein single-circle isolation.
Success rate of the pulmonary vein single-circle isolation.
Measured: Immediately after ablation
Secondary outcomes (8)
Total procedure time.
Time from the start to the end of the ablation procedure
Measured: Immediately after ablation
Left atrial operation time.
Left atrial operation time.
Measured: Immediately after ablation
The location and number of supplemental ablation.
The number and location of the supplemental ablation required for pulmonary vein isolation after single-circle ablation
Measured: Immediately after ablation
Intraoperative and postoperative stroke rates.
Intraoperative and postoperative stroke rates.
Measured: From the start of procedure to 7 days after ablation
Intraoperative and postoperative pericardial tamponade rates.
Intraoperative and postoperative pericardial tamponade rates.
Measured: From the start of procedure to 7 days after ablation
Number of steam pop during ablation.
Number of steam pop during ablation.
Measured: Immediately after ablation
the proportion of sinus rhythm within 1 year
Proportion of patients who successfully maintained sinus rhythm within 1 year after ablation.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start7 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuehui Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549714
- Sponsor's protocol ID
- AI-ablation
- Acronym
- AI-ablation
- Status last verified
- Sep 2020
- First submitted
- 7 Jun 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28639728Nakagawa 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.
PubMed 29600792Beinart 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.
PubMed 21615817
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Single Center, Randomized Controlled Trial of Quantitative Ablation of Pulmonary Vein Vestibule in Patients With Paroxysmal Atrial Fibrillation..
- ClinicalTrials.gov ID
- NCT04549714
- Acronym / sponsor ID
- AI-ablation / AI-ablation
- Conditions
- Atrial Fibrillation, Arrythmia
- Keywords
- Atrial Fibrillation, Ablation index, Quantitative Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yuehui YinUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High AI in paroxysmal atrial fibrillation | Experimental | Procedure: High AI in paroxysmal atrial fibrillationIn 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. |
| Middle AI in paroxysmal atrial fibrillation | Experimental | Procedure: Middle AI in paroxysmal atrial fibrillationIn 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. |
| Low AI in paroxysmal atrial fibrillation | Experimental | Procedure: Low AI in paroxysmal atrial fibrillationIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High AI in paroxysmal atrial fibrillationPatients 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. | Procedure or surgery | High AI in paroxysmal atrial fibrillation |
| Middle AI in paroxysmal atrial fibrillationPatients 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. | Procedure or surgery | Middle AI in paroxysmal atrial fibrillation |
| Low AI in paroxysmal atrial fibrillationPatients 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. | Procedure or surgery | Low AI in paroxysmal atrial fibrillation |
Primary outcome
Success rate of the pulmonary vein single-circle isolation.
Time frame: Immediately after ablation
Success rate of the pulmonary vein single-circle isolation.
8 secondary outcomes
Total procedure time.
Time frame: Immediately after ablation
Left atrial operation time.
Time frame: Immediately after ablation
The location and number of supplemental ablation.
Time frame: Immediately after ablation
Intraoperative and postoperative stroke rates.
Time frame: 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
Number of steam pop during ablation.
Time frame: Immediately after ablation
the proportion of sinus rhythm within 1 year
Time frame: 1 year
Recurrence rate of atrial fibrillation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 28639728Hussein 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.
- BackgroundNakagawa 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.
- Background: PubMed 29600792Taghji 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.
- Background: PubMed 21615817Beinart 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High AI in paroxysmal atrial fibrillation, Middle AI in paroxysmal atrial fibrillation and Low AI in paroxysmal atrial fibrillation in people with Atrial Fibrillation and Arrythmia, run by Yuehui Yin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhiyu Ling, MD (0086-13512362075, lingzy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the pulmonary vein single-circle isolation. (time frame: Immediately after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549714, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.