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Changes of Left Atrial Function and Quality of Life in Patients With Left Atrial Appendage Occlusion

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Left atrial appendage closure group
Radiofrequency ablation group
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, quality of life assessed, left atrial function

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with AF lasting for more than one year;
  2. Antiarrhythmic drugs are ineffective;
  3. Age of patients is less than 80 years old;
  4. Cha2ds2-vasc score ≥ 2;
  5. Not suitable for long-term oral anticoagulants.

Exclusion Criteria:

  1. Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation);
  2. Patients undergoing prosthetic heart valve replacement;
  3. Pregnant women;
  4. Patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Sites / Locations

  • The Second Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

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
changes of 6-minute walking test
6-minute walking test in meter
quality of life assessed
Shot Form 36 Health Survey Questionnaire:the higher the patient's score, the better the quality of life

Secondary Outcome Measures

Residual shunt after transcatheter closure of left atrial appendage detected
Transesophageal ultrasound
device-related thrombus after transcatheter closure of left atrial appendage detected
Transesophageal ultrasound
C creative protein
Blood samples are extracted in all patients to detected
B natriuretic peptide assessed
Blood samples are extracted in all patients to detected

Full Information

First Posted
May 3, 2020
Last Updated
September 20, 2021
Sponsor
Ruiqin xie
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1. Study Identification

Unique Protocol Identification Number
NCT04403412
Brief Title
Changes of Left Atrial Function and Quality of Life in Patients With Left Atrial Appendage Occlusion
Official Title
Short Term Changes of Left Atrial Function and Quality of Life in Patients With Atrial Fibrillation After Left Atrial Appendage Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
April 28, 2022 (Anticipated)
Study Completion Date
April 28, 2022 (Anticipated)

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

5. Study Description

Brief Summary
A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC), three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency ablation (1:1:1) were performed respectively. All patients were examined three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure left atrial (LA) function. The routine blood test and high-sensitivity C-reactive protein were performed in all patients before operation, 1 day and 1 month after operation. B-type natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute walking test and quality of life score before operation, 1 and 3 months after operation.
Detailed Description
A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC), three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency ablation (1:1:1) were performed respectively. All patients were examined by real-time three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure left atrial (LA) function. All ultrasound data will be stored and the professional director of the ultrasound room will be invited for quantitative analysis. The ultrasound indexes include: left atrial diameter, left atrial ejection fraction, etc. All patients underwent transesophageal echocardiography before operation and 3 months after the operation. Results two experienced ultrasound doctors judged whether there was left atrial thrombus, residual shunt and instrument surface related thrombus. The routine blood test and high-sensitivity C-reactive protein were performed in all patients before operation, 1 day and 1 month after operation. B-type natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute walking test and quality of life score before operation, 1 and 3 months after operation. At the same time, the thickness of crista was measured in all patients. This study will clarify the changes of left atrial function and biochemical quality in patients with AF after LAAC. In addition, this study also observed the effect of radiofrequency ablation combined with LAAC on left atrial function and evaluated whether one-stop surgery has more advantages than simple occlusion or ablation, and analyzed the above results. The patients were followed up for an average of three months to analyze the changes of left atrial function, quality of life and embolism events.

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, quality of life assessed, 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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left atrial appendage closure group
Arm Type
Experimental
Arm Title
Radiofrequency ablation group
Arm Type
Experimental
Arm Title
LAAC combined with radiofrequency ablation group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Left atrial appendage closure group
Intervention Description
Left atrial appendage closure 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 group
Intervention Description
Radiofrequency ablation 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
LAAC combined with radiofrequency ablation group 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- 3 month
Title
changes of 6-minute walking test
Description
6-minute walking test in meter
Time Frame
1- 3 month
Title
quality of life assessed
Description
Shot Form 36 Health Survey Questionnaire:the higher the patient's score, the better the quality of life
Time Frame
1- 3 month
Secondary Outcome Measure Information:
Title
Residual shunt after transcatheter closure of left atrial appendage detected
Description
Transesophageal ultrasound
Time Frame
1-3 month
Title
device-related thrombus after transcatheter closure of left atrial appendage detected
Description
Transesophageal ultrasound
Time Frame
1-3 month
Title
C creative protein
Description
Blood samples are extracted in all patients to detected
Time Frame
1-3 month
Title
B natriuretic peptide assessed
Description
Blood samples are extracted in all patients to detected
Time Frame
before and 3 month after operation

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: Patients with AF lasting for more than one year; Antiarrhythmic drugs are ineffective; Age of patients is less than 80 years old; Cha2ds2-vasc score ≥ 2; Not suitable for long-term oral anticoagulants. Exclusion Criteria: Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation); Patients undergoing prosthetic heart valve replacement; Pregnant women; Patients with previous liver and kidney diseases, malignant tumors or blood system diseases.
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ruiqin Xie, doctor
Phone
15803212537
Email
13230178060@163.com
First Name & Middle Initial & Last Name & Degree
ling You, doctor

12. IPD Sharing Statement

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Changes of Left Atrial Function and Quality of Life in Patients With Left Atrial Appendage Occlusion

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