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

NCT04403412 | Unknown

• 1 other identifier: XierqdoctorLAAO
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; left atrial appendage closure; quality of life assessed; left atrial function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Residual shunt after transcatheter closure of left atrial appendage detected

  1-3 month

• device-related thrombus after transcatheter closure of left atrial appendage detected

  1-3 month

• C creative protein

  1-3 month

• B natriuretic peptide assessed

  before and 3 month after operation

Study Arms (3)

Left atrial appendage closure group

EXPERIMENTAL

Procedure: Left atrial appendage closure group

Radiofrequency ablation group

EXPERIMENTAL

Procedure: Radiofrequency ablation group

LAAC combined with radiofrequency ablation group

EXPERIMENTAL

Procedure: LAAC combined with radiofrequency ablation group

Interventions

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

Left atrial appendage closure group

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.

Radiofrequency ablation group

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

LAAC combined with radiofrequency ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with AF lasting for more than one year;
• Antiarrhythmic drugs are ineffective;
• Age of patients is less than 80 years old;
• Cha2ds2-vasc score ≥ 2;
• Not suitable for long-term oral anticoagulants.

You may not qualify if:

• Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation);
• Patients undergoing prosthetic heart valve replacement;
• Pregnant women;
• Patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Sponsors & Collaborators

• Ruiqin xie: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of cardiology department

Model Details: 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).

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 27, 2020
• Study Start: February 1, 2020
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

CN (1)