Skip to content

Preoperative cardiac CT angiography for optimization of left atrial appendage closure in patients undergoing one-stop surgery for atrial fibrillation: a multicenter, randomized, controlled study

Preoperative cardiac CT angiography for optimization of left atrial appendage closure in patients undergoing one-stop surgery for atrial fibrillation: a multicenter, randomized, controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045961
Enrollment
Unknown
Registered
2021-04-30
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

Experimental group:Preoperative cardiac CT angiography
Control group:no

Sponsors

The Seventh People's Hospital of Zhengzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Symptomatic, non-valvular atrial fibrillation; 3. At least one anti-arrhythmic drug is ineffective, and there is an indication for RFCA for atrial fibrillation; 4. According to the CHA2DS2-VASc scoring system (assessment of stroke risk in patients with non-valvular atrial fibrillation), the score is >= 2 points (for women >= 3 points), and one of the following conditions is not suitable for long-term standard anticoagulation therapy; long-term standard anticoagulation Thromboembolic events still occur on the basis of coagulation therapy; according to the HAS-BLED scoring system (assessment of bleeding risk in patients with non-valvular atrial fibrillation), the score is >= 3; 5. CCTA evaluates that the maximum diameter of the mouth of each angle of LAA is <= 30mm, and it is estimated that the effective working depth of LAA is not less than 70% of the maximum diameter of the mouth; 6. Preoperative transthoracic echocardiography (TTE) to check the maximum anteroposterior diameter of the left atrium <= 50mm; 7. Subjects or authorized family members voluntarily accept clinical trials and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Congenital heart disease, valvular heart disease, unstable angina pectoris, acute myocardial infarction within three months, acute myocarditis, cardiomyopathy, pulmonary heart disease, severe neurological disease (severe disturbance of consciousness, severe Nervous system infections, etc.), mental diseases (drug abuse, drug dependence, mental disorders can not cooperate), abnormal thyroid function that cannot be controlled by drug treatment and surgical treatment, autoimmune diseases, blood system diseases, malignant tumors, serious infections; 2. At the same time combined with other bradyarrhythmias, such as atrioventricular block, sick sinus syndrome, etc.; at the same time combined with malignant ventricular arrhythmias, such as persistent ventricular tachycardia; 3. Percutaneous coronary intervention treatment is less than or equal to 12 months, and there is still one or more main blood vessels (anterior descending artery, circumflex artery, right coronary artery) after coronary angiography or percutaneous coronary intervention, which is greater than or equal to 95% narrow; 4. After standard treatment of cardiac function (NYHA New York Heart Function Classification) IV, or cardiac color Doppler ultrasound showing left ventricular ejection fraction 3 times the upper limit of normal) or abnormal renal function (SCr > 3.5mg/dl or CCr <30ml/min); 7. Those who have a history of cardiac surgery in the past 6 months; 8. There are contraindications for radiofrequency ablation (such as pregnancy status, allergy to contrast agents, etc.); 9. Life expectancy is less than 12 months; other patients who are not suitable for CCTA examination and DSA examination (such as claustrophobia, etc.); 10. Participated in other clinical research within 3 months before the date of obtaining the informed consent, or is participating in other clinical research.

Design outcomes

Primary

MeasureTime frame
Operation related complications ;instrument related complications;

Countries

China

Contacts

Public ContactZhao Yujie

The Seventh People's Hospital of Zhengzhou

lzyj74@126.com+86 18703677288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026