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

R

Ruiqin xie

Status

Unknown

Conditions

Atrial Fibrillation

Treatments

Procedure: Left atrial appendage closure group
Procedure: Radiofrequency ablation group
Procedure: LAAC combined with radiofrequency ablation group

Study type

Interventional

Funder types

Other

Identifiers

NCT04403412
XierqdoctorLAAO

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

105 participants in 3 patient groups

Left atrial appendage closure group
Experimental group
Treatment:
Procedure: Left atrial appendage closure group
Radiofrequency ablation group
Experimental group
Treatment:
Procedure: Radiofrequency ablation group
LAAC combined with radiofrequency ablation group
Experimental group
Treatment:
Procedure: LAAC combined with radiofrequency ablation group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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