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A New Theory of Electrophysiological Mechanism of Atrial Fibrillation (ANTEMAF)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PVI + SPEs ablation
PVI ablation
Sponsored by
The Second Affiliated Hospital of Kunming Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients undergoing a first-time ablation procedure for AF Paroxysmal AF will be defined as a sustained episode lasting > 7 days; Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 years; Long-lasting persistent AF will be more than 1 year and less than 5 years. Patients must be willing and able to comply with all peri-ablation and follow-up requirements. Patients with atrial fibrillation will to accept the procedure of ablation. Patients signed the written informed consent for the study. Patients can endure the required follow up. Exclusion Criteria: Patients with contraindications to systemic anticoagulation with heparin or a direct thrombin inhibitor. Patients with thromboembolus in left atrial appendage. Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view). Patients allergic for contrast or iodine. Patients with the serum creatinine（SCr） >3.5mg/dl Patients with life expectancy < 12 months Patients who are in the period of pregnant

Sites / Locations

  • The First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • The Second Affiliated Hospital of Kunming Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With additional SPEs ablation

Control Group

Arm Description

Patients who undergo PVI + SPEs ablation using ThermoCool SmartTouch catheter.

Patients who undergo PVI alone using ThermoCool SmartTouch catheter.

Outcomes

Primary Outcome Measures

Freedom from AF during follow-up
At the one-year follow-up，AF occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any AF episode that lasted for more than 30 seconds was categorized as a recurrence.

Secondary Outcome Measures

Acute success rate of AF termination during ablation procedure
Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.
Complications
Serious adverse events included death, pericardial tamponade , cerebrovascular events, significant PV stenosis , left atrial-esophageal fistula.

Full Information

First Posted
April 1, 2023
Last Updated
April 25, 2023
Sponsor
The Second Affiliated Hospital of Kunming Medical University
Collaborators
First Affiliated Hospital of Kunming Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05845034
Brief Title
A New Theory of Electrophysiological Mechanism of Atrial Fibrillation
Acronym
ANTEMAF
Official Title
A New Theory of Electrophysiological Mechanism of Atrial Fibrillation and Catheter Ablation Therapy for Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Kunming Medical University
Collaborators
First Affiliated Hospital of Kunming Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The electrophysiological mechanisms of atrial fibrillation remain disagreements. The goal of this clinical trail is to propose a new electrophysiological mechanism hypothesis of atrial fibrillation（AF）,meanwhile, the investigators sought to test the hypothesis that the superposition electrograms (SPEs) recorded during atrial fibrillation could be used as target sites for catheter ablation of atrial fibrillation.
Detailed Description
Catheter ablation for atrial fibrillation is a promising therapy, whose success is limited in part by uncertainty in the electrophysiological mechanisms of AF. The investigators recruited 100 subjects including paroxysmal(40%) and persistent (60%) AF. Cases were prospectively treated, in a 2-arm 1:1 design, by ablation SPEs followed by pulmonary vein isolation(PVI) ablation (n=50), or pulmonary vein isolation alone (n =50). All procedures are guided by CARTO (Biosense Webster) electroanatomic mapping system and ablation is performed using open irrigated catheters with contact force (CF) sensing (Thermocool SmartTouch, Biosense Webster). Study Group underwent electroanatomic mapping during AF. Using CARTO to identify areas associated with SPEs. Radiofrequency ablation of the area with SPEs was performed, aiming to eliminate SPEs and convert to sinus rhythm or atrial tachycardia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With additional SPEs ablation
Arm Type
Experimental
Arm Description
Patients who undergo PVI + SPEs ablation using ThermoCool SmartTouch catheter.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients who undergo PVI alone using ThermoCool SmartTouch catheter.
Intervention Type
Procedure
Intervention Name(s)
PVI + SPEs ablation
Intervention Description
electrophysiology substrate mapping is the critical difference between both groups.
Intervention Type
Procedure
Intervention Name(s)
PVI ablation
Intervention Description
electrophysiology substrate mapping is the critical difference between both groups.
Primary Outcome Measure Information:
Title
Freedom from AF during follow-up
Description
At the one-year follow-up，AF occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any AF episode that lasted for more than 30 seconds was categorized as a recurrence.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Acute success rate of AF termination during ablation procedure
Description
Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.
Time Frame
one year
Title
Complications
Description
Serious adverse events included death, pericardial tamponade , cerebrovascular events, significant PV stenosis , left atrial-esophageal fistula.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing a first-time ablation procedure for AF Paroxysmal AF will be defined as a sustained episode lasting > 7 days; Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 years; Long-lasting persistent AF will be more than 1 year and less than 5 years. Patients must be willing and able to comply with all peri-ablation and follow-up requirements. Patients with atrial fibrillation will to accept the procedure of ablation. Patients signed the written informed consent for the study. Patients can endure the required follow up. Exclusion Criteria: Patients with contraindications to systemic anticoagulation with heparin or a direct thrombin inhibitor. Patients with thromboembolus in left atrial appendage. Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view). Patients allergic for contrast or iodine. Patients with the serum creatinine（SCr） >3.5mg/dl Patients with life expectancy < 12 months Patients who are in the period of pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingli Zhou, M.D.
Phone
008613888163485
Email
3036425140@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Xu, M.M.
Phone
008615912598400
Email
527554438@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingli Zhou, M.D.
Organizational Affiliation
The Second Affiliated Hospital of Kunming Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baotong Hua, M.D.
Phone
008613708707901
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingli Zhou, M.D.
Phone
008613888163485
Email
3036425140@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9725923
Citation
Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.
Results Reference
result
PubMed Identifier
15172410
Citation
Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
Results Reference
result
PubMed Identifier
22818076
Citation
Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.
Results Reference
result

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A New Theory of Electrophysiological Mechanism of Atrial Fibrillation

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