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

Short Term Changes of Left Atrial Function and Quality of Life in Patients With Atrial Fibrillation After Left Atrial Appendage Occlusion

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Left atrial appendage closure group; Procedure: Radiofrequency ablation group; Procedure: LAAC combined with radiofrequency ablation group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: ruiqin Xie, doctor; Phone Number: 15803212537; Email: 13230178060@163.com
      • Contact: ling You, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left atrial appendage closure group	Procedure: Left atrial appendage closure group; Left atrial appendage closure Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography
Experimental: Radiofrequency ablation group	Procedure: Radiofrequency ablation group; 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.
Experimental: LAAC combined with radiofrequency ablation group	Procedure: LAAC combined with radiofrequency ablation group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left atrial function of postoperative left atrial appendage occlusion detected	Transthoracic ultrasound	1- 3 month
changes of 6-minute walking test	6-minute walking test in meter	1- 3 month
quality of life assessed	Shot Form 36 Health Survey Questionnaire：the higher the patient's score, the better the quality of life	1- 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual shunt after transcatheter closure of left atrial appendage detected	Transesophageal ultrasound	1-3 month
device-related thrombus after transcatheter closure of left atrial appendage detected	Transesophageal ultrasound	1-3 month
C creative protein	Blood samples are extracted in all patients to detected	1-3 month
B natriuretic peptide assessed	Blood samples are extracted in all patients to detected	before and 3 month after operation

Collaborators and Investigators

• Sponsor: Ruiqin xie

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): April 28, 2022
• Study Completion (Anticipated): April 28, 2022

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 23, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; left atrial appendage closure; left atrial function; quality of life assessed
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: XierqdoctorLAAO

Drug and device information, study documents

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