An interventional study of Cryoballoon ablation and Radiofrequency ablation in Persistent Atrial Fibrillation, sponsored by The Second Hospital of Hebei Medical University. Completed at 1 site in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by The Second Hospital of Hebei Medical University · Not applicable, Interventional, and Treatment
A total of 106 patients with drug-refractory persistent atrial fibrillation, who are planned to undergo circumferential pulmonary vein isolation (CPVI), will be randomly allocated into two groups. These patients will receive cryoballoon ablation, radiofrequency ablation under the guidance of 3D mapping respectively (allocation ratio, 1:1). Atrial electrical activity including atrial effective refractory period, atrial conduction time, electromechanical conduction time, P wave dispersion and spatial dispersion of atrial refractory will be measured before and after the operation. Left atrial appendage flow velocity of all patients are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of left atrial function are carried out for all patients before the operation and after the operation. Blood samples are extracted in all patients before the operation and after the operation.This study will clarify whether these different operation methods have different effects on the recovery of postoperative left atrial function and electrical activity in patients with persistent atrial fibrillation, and whether changes in left atrial function electrical activity are related to indicators such as inflammation, blood clotting and myocardial injury. Cryoballoons ablation is still less used to operate on persistent atrial fibrillation. To investigate the ablative effect, electrical remodeling and structural remodeling of persist atrial fibrillation with different operating methods. Therefore, the ablation is related indicators such as the success rate of the operation, intraoperative complications, postoperative recurrence rate and the amount of x-ray exposure are compared among two groups. At the same time, biochemical indicators of inflammation, blood clotting and myocardial injury such as blood routine, myocardial enzyme, BNP, troponin I and D-D dimmer are detected to analyze and determine which indicators are related to the postoperative recurrence of atrial fibrillation, the recovery of postoperative left atrial function.
From February 2018 to February 2020, the investigators enroll consecutive patients with drug-refractory persistent atrial fibrillation who were scheduled for an initial catheter ablation.Patients are divided in to two group: persistent AF in radiofrequency ablation group, cryoballoon ablation group.
Inclusion Criteria:Persistent
Exclusion Criteria:
•left ventricular dysfunction
Persistens atrial fibrillation in Cryoballoon ablation group will apply cryoablation
Procedure: Cryoballoon ablation
Persistens atrial fibrillation in Radiofrequency ablation group will apply Radiofrequency ablation
Procedure: Radiofrequency ablation
Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice. According to the objective condition, the operator determine whether or not to carry out an additional cryoablation. Then we will applicate electrophysiological substrate mapping for guiding ablation of atrial fibrillation,If mapping system detect a poor substrate,we should continue to ablate for left atrial roof and posterior line.
Each patient randomly allocated into the radiofrequency ablation group receives circumferential pulmonary vein isolation(CPVI),The default strategy is to create a circle surrounding the two ipsilateral pulmonary veins.We will mapping the left atrial subtrate. If mapping system detect a poor substrate,we should continue to ablate for left atrial roof and posterior line.
Change of P wave
Electrocardiogram
Time frame: 1-12 month
Atrial electrical activity
Electrophysiological examination
Time frame: During the operation
Left atrial function of postoperative
Transthoracic echocardiography
Time frame: 1-12 month
Plasma biomarkers of inflammation assessed
Blood samples are extracted in all patients to detected
Time frame: 1-12 month
B type natriuretic peptide assessed
Blood samples are extracted in all patients to detected
Time frame: 1-12 month
Coagulation index assessed
Blood samples are extracted in all patients to detected
Time frame: 1-6 month
homocysteine assessed
Blood samples are extracted in all patients to detected
Time frame: 1-12 month
β2-microglobulin assessed
Blood samples are extracted in all patients to detected
Time frame: 1-12 month
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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The Second Hospital of Hebei Medical University