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Effects of Different Surgical Methods for Persistent Atrial Fibrillation Combined With the Application of Statin Drugs on Left Atrial Function

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cryoballoon ablation
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 Persistent Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  • Persistent AF is defined as AF that persists without interruption for 7 days (electrocardiogram data or Holter), atrial fibrillation cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is <80 years.

Exclusion Criteria:

  • •left ventricular dysfunction

    • atrial thrombosis
    • valvular heart disease
    • hyperthyroidism
    • patients who underwent prosthetic heart valve replacement
    • patients with previous history of atrial fibrillation ablation
    • pregnant women
    • patients with existing liver and kidney disease
    • malignant tumors
    • hematological system diseases
    • patients who underwent prosthetic heart valve replacement

Sites / Locations

  • Second Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

pulmonary vein isolation

pulmonary vein and left atrial roof linear isol

Arm Description

patients will receive circumferential pulmonary vein isolation using cryoballoon ablation

patients will receive circumferential pulmonary vein and left atrial roof linear isolation using cryoballoon ablation

Outcomes

Primary Outcome Measures

Left atrial function of postoperative
Transthoracic echocardiography
Atrial electrical activity
Electrophysiological examination

Secondary Outcome Measures

C-Reactive Protein
Blood samples are extracted in all patients to detected
leukocyte assessed
Blood samples are extracted in all patients to detected
Neutrophil assessed
Blood samples are extracted in all patients to detected
Lymphocyte assessed
Blood samples are extracted in all patients to detected
Neutrophil/Lymphocyte
Blood samples are extracted in all patients to detected
B type natriuretic peptide assessed
Blood samples are extracted in all patients to detected
Coagulation index assessed
Blood samples are extracted in all patients to detected
Change of P wave
Electrocardiogram
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
August 28, 2018
Last Updated
March 17, 2021
Sponsor
The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03700307
Brief Title
Effects of Different Surgical Methods for Persistent Atrial Fibrillation Combined With the Application of Statin Drugs on Left Atrial Function
Official Title
Changes in Left Atrial Function After Respective Treatments of Persistent Atrial Fibrillation With Circumferential Pulmonary Vein Isolation, Circumferential Pulmonary Vein and Left Atrial Linear Isolation Using Cryoballoon Ablation and Effects of the Application of Statin Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
November 28, 2020 (Actual)
Study Completion Date
December 28, 2020 (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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
A total of 164 patients with persistent atrial fibrillation, who are planned to undergo treatment with cryoballoon ablation, will be randomly allocated into two groups. These patients will receive circumferential pulmonary vein isolation, circumferential pulmonary vein and left atrial roof linear isolation using cryoballoon ablation(allocation ratio, 1:1). Patients in each group will be randomly allocated into the statin treatment group and non-statin treatment group (allocation ratio, 1:1). Real-time 3D ultrasound and 2D ultrasound examinations and measurement of left atrial function are carried out for all patients before the operation, and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after the operation. Preoperative transesophageal echocardiography will be carried out in all patients to measure the left atrial appendage function. All ultrasound data will be stored and a professional director from the ultrasound room will be invited for quantitative analysis. Indicators for ultrasonography include: left atrial anterior and posterior diameter, left atrial volume, left atrial volume index, mitral e ", E peak, A peak, velocity time integral (VTI), left atrial ejection fraction, left atrial strain, strain rate and left atrial appendage emptying velocity. Blood samples are extracted in all patients to detect routine blood, troponin I, D-D dimer, oral anticoagulant monitoring and other biochemical parameters such as blood lipids before the operation and at 1, 2, 3 and 4 weeks and 1, 2 and 3 months after the operation. This study will clarify whether these different operation methods have different effects on the recovery of postoperative left atrial function in patients with persistent atrial fibrillation, and whether changes in left atrial function are related to indicators such as inflammation, blood clotting and myocardial injury. Furthermore, this study will investigate whether the application of statin drugs can improve postoperative left atrial function by affecting these indicators. In addition, the operation method has been improved targeting at the disadvantage of the greater amount of X-ray exposure during cryoballoon ablation for persistent atrial fibrillation. Circumferential pulmonary vein isolation is combined with left atrial roof linear isolation,and related indicators such as the success rate of the operation, intraoperative complications, postoperative recurrence rate and the amount of x-ray exposure are compared among two groups. At the same time, biochemical indicators of inflammation, blood clotting and myocardial injury such as blood routine, myocardial enzyme, troponin I and D-D dimmer are detected to analyze and determine which indicators are related to the postoperative recurrence of atrial fibrillation, the incidence of postoperative thrombosis and the recovery of postoperative left atrial function.
Detailed Description
A total of 164 patients with persistent atrial fibrillation(AF), who are planned to undergo treatment with cryoballoon ablation, will be randomly allocated into two groups. Each patient randomly allocated into the circumferential pulmonary vein isolation group receives circumferential pulmonary vein isolation using cryoballoon ablation, and no additional isolation or ablation is performed in the extrapulmonary sites unless the patient is diagnosed with right atrial flutter before the operation.The investigators will carry out tricuspid isthmus ablation during the operation for patients with a preoperative diagnosis of right atrial flutter. All patients will undergo the remodeling of pulmonary vein-left atrium under CT before the operation to understand the structures of the left atrium and pulmonary veins. Patients who have recurrent atrial fibrillations within the first three months during postoperative follow-up will not be considered for repeated the operation. Each patient randomly allocated into the circumferential pulmonary vein and left atrial linear isolation group receives circumferential pulmonary vein and left atrial roof linear isolation using cryoballoon ablation,no additional isolation or ablation is performed in the extra sites unless the patient is diagnosed with right atrial flutter before the operation. The investigators will carry out tricuspid isthmus ablation during the operation for patients with a preoperative diagnosis of right atrial flutter. All patients will undergo the remodeling of pulmonary vein-left atrium under CT before the operation to understand the structures of the left atrium and pulmonary veins. Patients who have recurrent atrial fibrillations within the first three months during postoperative follow-up will not be considered for repeated the operation. Cryoablation is performed using a single cryoballoon. The diameter of the cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter; Medtronic, Minneapolis, MN) is determined as 28 mm or 23 mm according to pulmonary venography results. After passing through the transseptal sheath, the cryoballoon catheter enters into the left atrium and is continuously infused with heparin saline through a 12 French(12F) oriented sheath. The circular mapping catheter (Achieve, Medtronic) will pass through the balloon catheter and first enter into the pulmonary vein lumen. It is placed as close as possible into the pulmonary vein to record original pulmonary vein potentials and carry out intraoperative real-time monitoring of the isolation of pulmonary vein potentials. The balloon is inflated at the entrance of the pulmonary vein. The mapping confirms that the balloon blocks the entrance of the pulmonary vein. After blocking of the entrance of the pulmonary vein is enhanced, liquid nitrogen is injected for cryoablation, which lasts for 240 seconds each time. Before performing right pulmonary vein ablation, a secondary catheter is placed into the superior vena cava during the cryoablation. A cycle length of 999 ms is taken to continuously make the right phrenic nerve pulsate. If diaphragm movement is weakened or disappears, the cryoablation will be immediately stopped. In general, the cryoablation of each pulmonary vein is carried out twice. If the cryoablation is unsuccessful for twice, an additional cryoablation can be carried out; but the number of times of pulmonary vein cryoablation should not be more than five.The patients randomly allocated into the circumferential pulmonary vein and left atrial linear isolation group receives circumferential pulmonary vein and left atrial roof linear isolation using cryoballoon ablation Examinations of real-time 3D ultrasound, 2D ultrasound, transesophageal echocardiography and Doppler are carried out to measure the left atrial size and function for all patients before the operation and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after the operation (iE33 machines equipped with X3, Philips). Measurement of left atrial anterior and posterior diameter: the left ventricular long axis next to the sternum is taken to measure the left atrial anterior and posterior diameter in the end systolic period of the left atrium; mitral e ": apical four-chamber view, sampling volume locates in the site of the mitral annular septum, and early diastolic blood flow velocity is measured; E peak: mitral valve early diastolic flow velocity; A peak: mitral valve late diastolic flow velocity; mitral valve velocity time integral. Measurement of left atrial ejection fraction: Five references sites are taken in the atrium, including four reference sites located in the front, lower, lateral and septal side of the top of the atrium, and one reference site located at the level of the mitral annulus. During the cardiac cycle, volumes at three time points will be measured. ① LAMax means that the left atrial volume is measured in the end systolic period before the opening and closing of the mitral valve, ② LAMin means that the left atrial volume is measured at end diastolic period before the closing of the mitral valve, and ③ LApreA means that the left atrial volume is measured before the appearance of the corresponding body surface ECG P-wave. These are obtained through the following formulas using the surface area index and left atrial function: the left atrial ejection fraction (LAEF) = [(LAMax- LAMin) / LAMax] × 100% - the active atrial emptying rate; the active left atrial emptying rate (LAactive) = [(LApreA - LAmin ) / LApreA] × 100% - passive atrial emptying rate; the passive left atrial emptying rate (LA passive) = [(LAmax - LApreA) / LAmax] × 100% - the atrial expansion index. The left atrial strain (four chambers, two-chamber): three reference sites are placed using Qlab software (CMQ, Philips Medical Systems). In four-chamber view, three reference sites are respectively placed in the mitral annular septum, the free wall of the mitral annulus and the top of the atrium. In two-chamber view, three reference sites are respectively placed in the front wall of the atrium, the free wall of the mitral annulus and the top of the atrium. The software will automatically track atrial muscle movement and work out the left atrial strain and left atrial strain rate. All patients will undergo preoperative transesophageal echocardiography to obtain the left atrial appendage (LAA) emptying velocity. Patients in the two groups of cryoballoon ablation, will be randomly allocated again into the statin treatment group and non-statin treatment group. Patients in the statin treatment group will orally receive 20 mg of atorvastatin per night (Pfizer) for three days before the operation and three months after the operation. Forms are filled in for all patients before the operation to record medical histories and related biochemical parameters in detail (including all blood routine indicators [Neutrophil%(NE%), Lymphocyte% (LY%), NE/LY], International Normalized Ratio (INR), enzymes, troponin, blood lipids and D-D dimer). The above-mentioned blood biochemical parameters are reexamined for all patients at 1, 2, 3 and 4 weeks and 1, 2 and 3 months after the operation. In addition to the above-described echocardiographic reexamination and blood samples, the content of the follow-up after ablation also includes symptoms, complications, electrocardiogram and 24-hour dynamic electrocardiogram.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulmonary vein isolation
Arm Type
Experimental
Arm Description
patients will receive circumferential pulmonary vein isolation using cryoballoon ablation
Arm Title
pulmonary vein and left atrial roof linear isol
Arm Type
Experimental
Arm Description
patients will receive circumferential pulmonary vein and left atrial roof linear isolation using cryoballoon ablation
Intervention Type
Procedure
Intervention Name(s)
Cryoballoon ablation
Intervention Description
Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice.
Primary Outcome Measure Information:
Title
Left atrial function of postoperative
Description
Transthoracic echocardiography
Time Frame
1-12 month
Title
Atrial electrical activity
Description
Electrophysiological examination
Time Frame
During the operation
Secondary Outcome Measure Information:
Title
C-Reactive Protein
Description
Blood samples are extracted in all patients to detected
Time Frame
1-12 month
Title
leukocyte assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
1-12 month
Title
Neutrophil assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
1-12 month
Title
Lymphocyte assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
1-12 month
Title
Neutrophil/Lymphocyte
Description
Blood samples are extracted in all patients to detected
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
Coagulation index assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
1-6 month
Title
Change of P wave
Description
Electrocardiogram
Time Frame
1-12 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
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persistent AF is defined as AF that persists without interruption for 7 days (electrocardiogram data or Holter), atrial fibrillation cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is <80 years. Exclusion Criteria: •left ventricular dysfunction atrial thrombosis valvular heart disease hyperthyroidism patients who underwent prosthetic heart valve replacement patients with previous history of atrial fibrillation ablation pregnant women patients with existing liver and kidney disease malignant tumors hematological system diseases patients who underwent prosthetic heart valve replacement
Facility Information:
Facility Name
Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China

12. IPD Sharing Statement

Learn more about this trial

Effects of Different Surgical Methods for Persistent Atrial Fibrillation Combined With the Application of Statin Drugs on Left Atrial Function

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