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Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Left atrial appendage closure
Radiofrequency ablation
LAAC combined with radiofrequency ablation group
Sponsored by
Ruiqin xie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, left atrial appendage closure, left atrial function

Eligibility Criteria

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

Inclusion Criteria:

  • persistent atrial fibrillation episode occurs in the patient that lasting longer than one year,
  • atrial fibrillation 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 atrial fibrillation ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation),
  • 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

Other

Experimental

Arm Label

Left atrial appendage closure group

Radiofrequency ablation group

LAAC combined with radiofrequency ablation group

Arm Description

Outcomes

Primary Outcome Measures

Left atrial function of postoperative left atrial appendage occlusion detected
Transthoracic ultrasound

Secondary Outcome Measures

Plasma biomarkers of inflammation assessed
Blood samples are extracted in all patients for the detection of the C reactive protein, white blood cell,red blood cell, Platelets,neutrophile and lymphocytes.
B natriuretic peptide assessed
Blood samples are extracted in all patients to detected
Coagulation index assessed
Blood samples are extracted in all patients to detected

Full Information

First Posted
September 1, 2017
Last Updated
March 17, 2021
Sponsor
Ruiqin xie
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1. Study Identification

Unique Protocol Identification Number
NCT03276169
Brief Title
Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation
Official Title
Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ruiqin xie

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 105 patients with persistent atrial fibrillation(AF), that lasting longer than one year and planned to undergo surgical treatment, will be allocated into three groups. These patients will receive left atrial appendage closure(LAAC), radiofrequency ablation under the guidance of 3D mapping and LAAC combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1). Real-time 3D ultrasound and 2D ultrasound examinations and measurement of left ventricle(LV) and left atrial(LA) 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. All ultrasound data will be stored and a professional director from the ultrasound room will be invited for quantitative analysis. Indicators for ultrasonography include: LV ejection fraction(LVEF), LV end-diastolic volume, Stroke volume, 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, and strain rate. Blood samples are extracted in all patients to detect type B natriuretic peptide before the operation and at 1, 2, 3 days and 1,3,6,12 months after the operation. Blood samples are extracted in all patients to detect routine blood, coagulation, D-D dimmer,Inflammatory markers (hsCRP) and other biochemical parameters before the operation and at 1, 2, 3 and 4 weeks and 1, 2, 3,6and 12 months after the operation. At the same time in operation LA pressure in all patients will be measured preoperatively and postoperatively. This study will clarify the short-term and long-term changes of LA pressure and function of patients with persistent AF after LAAC, and whether changes in left atrial pressure and function are related to inflammation indicators. This study will also to observe whether the coagulation indexes changed after LAAC that can be used to know whether the LAAC activates the coagulation system. In addition, this study to investigate the effects of radiofrequency ablation combined with LAAC on left atrial pressure and function, changes of blood coagulation and inflammatory markers, and to analyze the above findings. At an average follow-up of one year, changes in left atrial function, inflammation, coagulation, and embolic events were analyzed early (3 months after surgery) and late (1 years after surgery).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, left atrial appendage closure, left atrial function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 105 patients with persistent atrial fibrillation(AF), who are persistented more than one year and planned to undergo surgical treatment, will be allocated into two groups. These patients will receive left atrial appendage closure, radiofrequency ablation under the guidance of 3D mapping and left atrial appendage closure combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1).
Masking
ParticipantOutcomes Assessor
Masking Description
The researchers will participate in the operation to record operative parameters such as LA pressure. Other researchers including follow-up personnel and the ultrasonic data analyst are uninformed about the random situation of the patients (patient information is recorded according to the random number. Random numbers corresponding to the random allocation list are stored in the research center. After follow-up of the last patient is completed, the random allocation list is published by the random number designer; and the designer does not participate in the data collection and statistics.)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left atrial appendage closure group
Arm Type
Experimental
Arm Title
Radiofrequency ablation group
Arm Type
Other
Arm Title
LAAC combined with radiofrequency ablation group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Left atrial appendage closure
Intervention Description
Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.
Intervention Type
Procedure
Intervention Name(s)
LAAC combined with radiofrequency ablation group
Intervention Description
Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
Primary Outcome Measure Information:
Title
Left atrial function of postoperative left atrial appendage occlusion detected
Description
Transthoracic ultrasound
Time Frame
1-12 month
Secondary Outcome Measure Information:
Title
Plasma biomarkers of inflammation assessed
Description
Blood samples are extracted in all patients for the detection of the C reactive protein, white blood cell,red blood cell, Platelets,neutrophile and lymphocytes.
Time Frame
1-12 month
Title
B 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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: persistent atrial fibrillation episode occurs in the patient that lasting longer than one year, atrial fibrillation 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 atrial fibrillation ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation), 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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Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation

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