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The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiofrequency ablation or cryoballoon
Sponsored by
The Second Hospital of Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, atrial electrical remodeling

Eligibility Criteria

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

Inclusion Criteria:

  • paroxysmal AF episode occurs in the patient at least twice within half a year (electrocardiogram data or Holter), AF cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is ≤80 years.

Exclusion Criteria:

  • patients with previous history of AF ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation), left atrium (LA) >50 mm, patients who underwent prosthetic heart valve replacement, pregnant women, patients with existing liver and kidney disease, malignant tumors or hematological system diseases.

Sites / Locations

  • The Second Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

paroxysmal AF with radiofrequency ablation

persistent AF with radiofrequency ablation group

paroxysmal AF with cryoballoon group

Arm Description

radiofrequency catheter ablation therapy

radiofrequency catheter ablation therapy

cryoballoon ablation therapy

Outcomes

Primary Outcome Measures

Change of P wave
Electrocardiogram
Atrial effective refractory period
Electrophysiological examination

Secondary Outcome Measures

Plasma biomarkers of inflammation assessed
Blood samples are extracted in all patients for the detection of routine blood, high sensitivity c-reactive protein in mg/L,cystatin C in mg/L.
B type natriuretic peptide assessed
Blood samples are extracted in all patients to detected
Left atrial function
Transthoracic echocardiography
Coagulation index assessed
Blood samples are extracted in all patients to detected
homocysteine assessed
Blood samples are extracted in all patients to detected
β2-microglobulin assessed
Blood samples are extracted in all patients to detected

Full Information

First Posted
September 28, 2017
Last Updated
March 17, 2021
Sponsor
The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03322085
Brief Title
The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical
Official Title
The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical Remodeling and the Relationship Between Electrical Remodeling and Structural Remodeling
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study explored the influence of radiofrequency catheter ablation and cryoballoon ablation on atrial electrical remodeling in patients with atrial fibrillation,the relationship between atrial electrical remodeling and structural remodeling,and which indicators are associated with atrial recurrence after catheter ablation.
Detailed Description
From September 2017 to September 2019, the investigators enroll consecutive patients with symptomatic atrial fibrillation (AF) who were scheduled for an initial catheter ablation, including paroxysmal and persistent AF.Patients are divided in to three group: paroxysmal AF in radiofrequency ablation group, persistent AF in radiofrequency ablation group, and paroxysmal AF in Cryoablation group. Paroxysmal AF group: The p-wave duration, P wave dispersion and P wave amplitude are detected before and 24 hours after procedure.The atrial effective refractory period, refractory period dispersion, frequency adaptation and atrial conduction time were tested before and after procedure. Detect atrial electromechanical conduction time in the tissue doppler before and 1 week after procedure. Persistent AF group: The p-wave duration, P wave dispersion and P wave amplitude are detected 24 hours after procedure.The atrial effective refractory period, refractory period dispersion, frequency adaptation and atrial conduction time were tested after procedure. Detect atrial electromechanical conduction time in the tissue doppler 1 week after procedure. Method of detection of atrial electrical remodeling: 1). the measurement of surface electrocardiogram: the p-wave amplitude, P wave time duration and the p-wave duration dispersion (dP =Pmax- Pmin) of the same 12 lead electrocardiogram in the same cardiac cycle.Two cardiologists measured the value separately.The investigators record the mean value. 2). Atrial effective refractory period (AERP) measured from the high right atrium(HRA,the junction of superior vena cava and the right atrium , near the sinus node), low lateral right atrium(LLRA,the junction of inferior vena cava and the right atrium,on the right atrium free wall side), coronary sinus electrode (CS)7.8, and CS1.2 at 3 basic drive cycle lengths (CLs) of 600, 500, and 400 ms. Pacing was performed using a pulse width of 2 ms and a current output of twice the local diastolic threshold. If the latter was 2.0 milliampere (mA), the catheter was replaced and the threshold repeated. AERP was measured using an 8-beat drive train and a single extrastimulus incremented by 10 ms from a starting point of 170 ms. Every AERP was repeated 3 times, and the mean was taken. 3). At each CL, the dispersion of refractoriness was measured by subtracting the minimum from the maximum AERP across the 4 sites. Rate adaption of AERP: With the gradual shortening of the pacing cycle lengths, the atrial effective refractory should be shortened accordingly. The rate adaption of AERP was observed in different pacing cycle lengths. Atrial conduction time measured at the HRA after 30 seconds of constant pacing at a CL of 600, 500, and 400 ms. Conduction time is measured from the pacing artifact to the onset of the first initial sharp deflection recorded to the first A wave at CS1.10 and CS1.2. Total atrial conduction time=Pace HRA-Acs1.2; Right atrial conduction time=PaceHRA-Acs9.10; Left atrial conduction time=Acs9.10-Acs1.2.6). Atrial electromechanical conduction time: three sampling points are taken at lateral mitral valve(Sa1), septal mitral valve(Sa2), lateral tricuspid valve (Sa3), in the tissue doppler four-chamber view. Atrial electromechanical conduction time is measured from electrocardiogram P wave initiation to ultrasound A wave initiation. Total atrial electromechanical conduction time=T1-T3;Right atrial electromechanical conduction time=T2-T3; Light atrial electromechanical conduction time=T2-T1. All patients fill the follow-up form before procedure. After catheter ablation therapy, all patients invited to come back to the outpatient clinic every week in the first month, and then at 2, 3, 6, 9, and 12 month to follow up. Patients received electrocardiogram and Holter monitor examination if with symptoms of palpitations. Those patients with no symptoms received electrocardiogram every month and Holter monitor examination every 6 months. Recurrence of atrial fibrillation was defined as atrial fibrillation/flutter or atrial tachycardia lasting ≥ 30 seconds 3 months after radiofrequency catheter ablation therapy. Patients who have AF recurrence within three months after therapy will not be considered for repeated radiofrequency ablation.Blood samples (routine blood, high sensitivity c-reactive protein,B-type natriuretic peptide (BNP), cystatin C,homocysteine,β2-microglobulin) and transthoracic echocardiography indexes (left atrial anterior to posterior diameter, left atrial length-diameter,left atrial transverse-diameter,left atrial volume index, mitral e', E peak, A peak, E/A,velocity time integral (VTI), left atrial ejection fraction, left atrial strain, strain rate and atrial electrical - mechanical conduction time) are recorded in all patients at each follow-up. Patients with AF recurrence must have an electrocardiogram or a 24 hour holter monitor evidence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, atrial electrical remodeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paroxysmal AF with radiofrequency ablation
Arm Type
Experimental
Arm Description
radiofrequency catheter ablation therapy
Arm Title
persistent AF with radiofrequency ablation group
Arm Type
Experimental
Arm Description
radiofrequency catheter ablation therapy
Arm Title
paroxysmal AF with cryoballoon group
Arm Type
Experimental
Arm Description
cryoballoon ablation therapy
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation or cryoballoon
Intervention Description
Patients in radiofrequency ablation group receive circumferential pulmonary vein isolation,and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation. And Cryoablation is performed using a single cryoballoon. The diameter of the cryoballoon is determined as 28 mm or 23 mm according to pulmonary venography results.
Primary Outcome Measure Information:
Title
Change of P wave
Description
Electrocardiogram
Time Frame
1-12 month
Title
Atrial effective refractory period
Description
Electrophysiological examination
Time Frame
During the operation
Secondary Outcome Measure Information:
Title
Plasma biomarkers of inflammation assessed
Description
Blood samples are extracted in all patients for the detection of routine blood, high sensitivity c-reactive protein in mg/L,cystatin C in mg/L.
Time Frame
1-12 month
Title
B type natriuretic peptide assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
1-12 month
Title
Left atrial function
Description
Transthoracic echocardiography
Time Frame
1-12month
Title
Coagulation index assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
1-6 month
Title
homocysteine assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
1-12 month
Title
β2-microglobulin assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
1-12 month

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: paroxysmal AF episode occurs in the patient at least twice within half a year (electrocardiogram data or Holter), AF cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is ≤80 years. Exclusion Criteria: patients with previous history of AF ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation), left atrium (LA) >50 mm, patients who underwent prosthetic heart valve replacement, pregnant women, patients with existing liver and kidney disease, malignant tumors or hematological system diseases.
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical

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