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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04403412
• Other study ID #: XierqdoctorLAAO
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: April 28, 2022

Study information

• Verified date: September 2021
• Source: The Second Hospital of Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Ruiqin xie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left atrial function of postoperative left atrial appendage occlusion detected	Transthoracic ultrasound	1- 3 month
Primary	changes of 6-minute walking test	6-minute walking test in meter	1- 3 month
Primary	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	Residual shunt after transcatheter closure of left atrial appendage detected	Transesophageal ultrasound	1-3 month
Secondary	device-related thrombus after transcatheter closure of left atrial appendage detected	Transesophageal ultrasound	1-3 month
Secondary	C creative protein	Blood samples are extracted in all patients to detected	1-3 month
Secondary	B natriuretic peptide assessed	Blood samples are extracted in all patients to detected	before and 3 month after operation