Last updated: May 27, 2022
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dysrhythmia
Chest Pain
Arrhythmia
Treatment
N/AClinical Study ID
NCT05400928
JJETCT2021002
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Paroxysmal Atrial Fibrillation (PAF)
Exclusion
Exclusion Criteria:
- A history of atrial fibrillation ablation;
- Left ventricular ejectfraction(LVEF)<35%
- Left Atrium(LA)(echocardiography)>55mm
- Thrombus in the left atrial or heart before surgery
- New York Heart Association(NYHA) grade Ⅲ-Ⅳ
- second or third degree atrioventricular block
- Significant congenital heart defects (e.g. atrial septal defect or severe pulmonaryvein stenosis, but except foramen ovale)
- Prosthetic valves
- Pacemakers or defibrillators (ICD)
- Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma
- Symptomatic carotid stenosis
- Untreated or uncontrolled hyperthyroidism or hypothyroidism
- Systemic active infection
- Renal failure with obvious bleeding tendency or undergoing hemodialysis
- Myocardial infarction or any cardiac intervention/open surgery within 3 months
- Stroke or transient ischemic attack within 6 months
- Obvious contraindication for interventional surgery who were determined by theinvestigator to be unable to undergo ablation
- Pregnant or lactating women or those who planned to have a family during the studyperiod
- Have participated in clinical trials of other drugs or medical devices within 3 months
- Unsuitable to participate in this clinical trial by the investigator
Study Design
Total Participants: 144
Study Start date:
July 05, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Tongji Hospital
Wuhan, Hubei 430030
ChinaActive - Recruiting

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