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Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03276169
Recruitment Status : Not yet recruiting
First Posted : September 8, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ruiqin xie, The Second Hospital of Hebei Medical University

Brief Summary:
A total of 105 patients with persistent atrial fibrillation(AF), that lasting longer than one year and planned to undergo surgical treatment, will be allocated into three groups. These patients will receive left atrial appendage closure(LAAC), radiofrequency ablation under the guidance of 3D mapping and LAAC combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1). Real-time 3D ultrasound and 2D ultrasound examinations and measurement of left ventricle(LV) and left atrial(LA) function are carried out for all patients before the operation, and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after the operation. All ultrasound data will be stored and a professional director from the ultrasound room will be invited for quantitative analysis. Indicators for ultrasonography include: LV ejection fraction(LVEF), LV end-diastolic volume, Stroke volume, left atrial anterior and posterior diameter, left atrial volume, left atrial volume index, mitral e ", E peak, A peak, velocity time integral (VTI), left atrial ejection fraction, left atrial strain, and strain rate. Blood samples are extracted in all patients to detect type B natriuretic peptide before the operation and at 1, 2, 3 days and 1,3,6,12 months after the operation. Blood samples are extracted in all patients to detect routine blood, coagulation, D-D dimmer,Inflammatory markers (hsCRP) and other biochemical parameters before the operation and at 1, 2, 3 and 4 weeks and 1, 2, 3,6and 12 months after the operation. At the same time in operation LA pressure in all patients will be measured preoperatively and postoperatively. This study will clarify the short-term and long-term changes of LA pressure and function of patients with persistent AF after LAAC, and whether changes in left atrial pressure and function are related to inflammation indicators. This study will also to observe whether the coagulation indexes changed after LAAC that can be used to know whether the LAAC activates the coagulation system. In addition, this study to investigate the effects of radiofrequency ablation combined with LAAC on left atrial pressure and function, changes of blood coagulation and inflammatory markers, and to analyze the above findings. At an average follow-up of one year, changes in left atrial function, inflammation, coagulation, and embolic events were analyzed early (3 months after surgery) and late (1 years after surgery).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Left atrial appendage closure Procedure: Radiofrequency ablation Procedure: LAAC combined with radiofrequency ablation group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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.)
Primary Purpose: Treatment
Official Title: Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Left atrial appendage closure group Procedure: 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 Procedure: 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
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 Measures :
  1. Left atrial function of postoperative left atrial appendage occlusion detected [ Time Frame: 1-12 month ]
    Transthoracic ultrasound


Secondary Outcome Measures :
  1. Plasma biomarkers of inflammation assessed [ Time Frame: 1-12 month ]
    Blood samples are extracted in all patients for the detection of the C reactive protein, white blood cell,red blood cell, Platelets,neutrophile and lymphocytes.

  2. B natriuretic peptide assessed [ Time Frame: 1-12 month ]
    Blood samples are extracted in all patients to detected

  3. Coagulation index assessed [ Time Frame: 1-6 month ]
    Blood samples are extracted in all patients to detected



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • persistent atrial fibrillation episode occurs in the patient that lasting longer than one year,
  • atrial fibrillation cannot be prevented in patients who orally take class I and III antiarrhythmic drugs,
  • and patient age is <80 years.

Exclusion Criteria:

  • patients with previous history of atrial fibrillation ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation),
  • patients who underwent prosthetic heart valve replacement,
  • pregnant women,
  • patients with existing liver and kidney disease, malignant tumors or hematological system diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276169


Contacts
Contact: ruiqin Xie, doctor 15803212537 132301788060@163.com

Locations
China, Hebei
The Second Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 050000
Contact: ruiqin Xie, doctor    15803212537    13230178060@163.com   
Contact: ling You, doctor         
Sponsors and Collaborators
Ruiqin xie

Responsible Party: Ruiqin xie, director of cardiology department, The Second Hospital of Hebei Medical University
ClinicalTrials.gov Identifier: NCT03276169     History of Changes
Other Study ID Numbers: xierqdoctorLAAC
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ruiqin xie, The Second Hospital of Hebei Medical University:
atrial fibrillation
left atrial appendage closure
left atrial function

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes