NCT04549714

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 7, 2019

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

June 7, 2019

Last Update Submit

September 14, 2020

Conditions

Atrial FibrillationArrythmia

Keywords

Atrial FibrillationAblation indexQuantitative Ablation

Outcome Measures

Primary Outcomes (1)

  • Success rate of the pulmonary vein single-circle isolation.

    Success rate of the pulmonary vein single-circle isolation.

    Immediately after ablation

Secondary Outcomes (8)

  • Total procedure time.

    Immediately after ablation

  • Left atrial operation time.

    Immediately after ablation

  • The location and number of supplemental ablation.

    Immediately after ablation

  • Intraoperative and postoperative stroke rates.

    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

  • +3 more secondary outcomes

Study Arms (3)

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.

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.

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.

Procedure: Low AI in paroxysmal atrial fibrillation

Interventions

High AI in paroxysmal atrial fibrillationPROCEDURE

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.

High AI in paroxysmal atrial fibrillation
Middle AI in paroxysmal atrial fibrillationPROCEDURE

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.

Middle AI in paroxysmal atrial fibrillation
Low AI in paroxysmal atrial fibrillationPROCEDURE

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.

Low AI in paroxysmal atrial fibrillation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affilliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28639728BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 29600792BACKGROUND

  • 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.

    PMID: 21615817BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

zhiyu Ling, MD

CONTACT

0086-13512362075lingzy@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patients enrolled in the study were randomly assigned to different surgical groups using random envelopes. All study personnel were blind to treatment allocation and had no way of influencing whether a participant would receive high or low AI ablation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Department

Study Record Dates

First Submitted

June 7, 2019

First Posted

September 16, 2020

Study Start

June 7, 2019

Primary Completion

December 31, 2020

Study Completion

August 31, 2021

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

CN(1)