Trials / Unknown
UnknownNCT04403412
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- Ruiqin xie · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
Timeline
- Start date
- 2020-02-01
- Primary completion
- 2022-04-28
- Completion
- 2022-04-28
- First posted
- 2020-05-27
- Last updated
- 2021-09-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04403412. Inclusion in this directory is not an endorsement.