Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
80

Summary

Conditions
Cardiovascular Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

From September 2017, 20 selective patients, and then 120 consecutive patients with valvular atrial fibrillation were treated with our new operation. If the clinical results from the first 20 patients with restrict selection criteria are unsatisfied, that is, the restoration rate of the sinus rhythm ...

From September 2017, 20 selective patients, and then 120 consecutive patients with valvular atrial fibrillation were treated with our new operation. If the clinical results from the first 20 patients with restrict selection criteria are unsatisfied, that is, the restoration rate of the sinus rhythm was less than 50% at 1-year follow up, the study will be stopped. Otherwise, another single arm with 120 consecutive patients with valvular AF will be recruited for next phase. After a median sternotomy, cardiopulmonary bypass was established by standard aorta and inferior vena cava cannulation, whereas a bidirectional right-angle venous cannula was placed within the innominate vein. Myocardial protection was obtained by multiple administration of cold blood cardioplegia. The superior vena cava was circumferentially mobilized from the pulmonary artery and pericardium and was transected at least 3 cm cephalad to its entry into the right atrium. Two circular incisions were usually performed in the left atrial wall between the pulmonary veins and the mitral annulus. The first one was made in the right atrial free wall, about 5 mm inside the right pulmonary veins and parallel to the interatrial groove, and extended around the pulmonary veins, in order to isolate the posterior wall containing pulmonary veins (called pulmonary vein island). The second incision was made in the interatrial groove and extended around the posterior mitral annulus (leaving about a 2 cm posterior margin from the annulus). With those two incisions, a circumferential ban of the left atrial wall was excised. The base of the left atrial appendage was ligated. All the resected margin of the left atrium was thoroughly cauterized to prevent bleeding from the small vessels of the epicardial tissue. At the same time, the excised tissues will be preserved properly for further research. The middle of pulmonary vein island was longitudinal plicated. Finally,the plicated pulmonary island was directly anastomosed to the left side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Telephone contact was maintained with the patients after discharge.The use of antiarrhythmic medications was allowed during the first 3 months(blanking period). 12-lead electrocardiograms, and 24-hour Holter-monitor recordings were obtained at baseline and at 3, 6, 9, and 12 months after the initial operation. Whenever the participants had symptoms such as palpitation, dizziness, or shortness of breath, they should telephone the doctors. The primary end point is freedom from any documented episode of atrial fibrillation lasting longer than 30 seconds and occurring after the operation.The secondary end point are the survive rate, complication, reoperation rate, security index perioperatively, life quality postoperatively. Statistical analysis were performed with statistic package for social science( SPSS) 11.5 software. A value of P < 0.05 was considered statistically significant.

Tracking Information

NCT #
NCT03347695
Collaborators
Not Provided
Investigators
Study Director: Liangwan Chen, M.D Union Hospital