The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
NCT Number: NCT03443232
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.
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Notify MeUp to 80 year
All sexes
Interventional
Not applicable
Shijiazhuang, Hebei, 050000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Persistent
Exclusion criteria
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.
Time frame: 1-12 month
Electrocardiogram
Time frame: During the operation
Electrophysiological examination
Time frame: 1-12 month
Transthoracic echocardiography
Time frame: 1-12 month
Blood samples are extracted in all patients to detected
Time frame: 1-12 month
Blood samples are extracted in all patients to detected
Time frame: 1-6 month
Blood samples are extracted in all patients to detected
Time frame: 1-12 month
Blood samples are extracted in all patients to detected
Time frame: 1-12 month
Blood samples are extracted in all patients to detected
The Second Hospital of Hebei Medical University
Other
The Effect of Cryoballoon and Radiofrequency Ablations on Left Atrial Structural and Electrical Remodeling in Patients With Drug-refractory Persistent Atrial Fibrillation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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