The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical

The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical Remodeling and the Relationship Between Electrical Remodeling and Structural Remodeling

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: radiofrequency ablation or cryoballoon

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: paroxysmal AF with radiofrequency ablation; radiofrequency catheter ablation therapy	Procedure: radiofrequency ablation or cryoballoon; 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.
EXPERIMENTAL: persistent AF with radiofrequency ablation group; radiofrequency catheter ablation therapy	Procedure: radiofrequency ablation or cryoballoon; 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.
EXPERIMENTAL: paroxysmal AF with cryoballoon group; cryoballoon ablation therapy	Procedure: radiofrequency ablation or cryoballoon; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of P wave	Electrocardiogram	1-12 month
Atrial effective refractory period	Electrophysiological examination	During the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B type natriuretic peptide assessed	Blood samples are extracted in all patients to detected	1-12 month
Coagulation index assessed	Blood samples are extracted in all patients to detected	1-6 month
homocysteine assessed	Blood samples are extracted in all patients to detected	1-12 month
β2-microglobulin assessed	Blood samples are extracted in all patients to detected	1-12 month
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.	1-12 month
Left atrial function	Transthoracic echocardiography	1-12month

Collaborators and Investigators

• Sponsor: The Second Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 30, 2019

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (ACTUAL): October 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: atrial fibrillation; atrial electrical remodeling
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Remodeling
• Other Study ID Numbers: xierqdoctorER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No