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

NCT03700307 | Completed

• 1 other identifier: XieruiqindoctorAF
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Left atrial function of postoperative

  Transthoracic echocardiography

  1-12 month

• Atrial electrical activity

  Electrophysiological examination

  During the operation

Secondary Outcomes (10)

• C-Reactive Protein

  1-12 month

• leukocyte assessed

  1-12 month

• Neutrophil assessed

  1-12 month

• Lymphocyte assessed

  1-12 month

• Neutrophil/Lymphocyte

  1-12 month

Study Arms (2)

pulmonary vein isolation

EXPERIMENTAL

patients will receive circumferential pulmonary vein isolation using cryoballoon ablation

Procedure: Cryoballoon ablation

pulmonary vein and left atrial roof linear isol

EXPERIMENTAL

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

Procedure: Cryoballoon ablation

Interventions

Cryoballoon ablation PROCEDURE

Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice.

pulmonary vein and left atrial roof linear isol; pulmonary vein isolation

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of cardiology department

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: October 9, 2018
• Study Start: August 28, 2018
• Primary Completion: November 28, 2020
• Study Completion: December 28, 2020
• Last Updated: March 18, 2021

Record last verified: 2020-03

Locations

CN (1)