Actively Recruiting
The Impact of Atrial Pressure Change Before and After Combined Procedure
Led by Shanghai 10th People's Hospital · Updated on 2022-09-02
100
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
One-stop procedure combining catheter ablation (CA) and left atrial appendage closure (LAAC) has been a feasible treatment for patients with atrial fibrillation at high risk of stroke and/or bleeding. Although it could achieve considerable rhythm control and stroke prophylaxis, a number of patients has experienced progressive heart failure after the procedure. Notably, previous studies indicate that both pulmonary vein isolation by CA and LAAC could significantly increase left atrial pressure, while currently no study has investigated left atrial pressure change in patients underwent combined procedure. The investigators hypothesise that combined procedure would significantly increase left atrial pressure and subsequently deteriorate cardiac function. Therefore, the investigators aim to measure the left and right atrial pressure change before and after CA and LAAC in combined procedure, and investigate the influence of the pressure change on clinical outcomes.
CONDITIONS
Official Title
The Impact of Atrial Pressure Change Before and After Combined Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Atrial fibrillation recorded by 12-lead ECG or Holter lasting longer than 30 seconds within the last 6 months
- Eligible for left atrial appendage closure by meeting at least one of: high risk of stroke (CHA2DS2-VASc score ≥3 in females, ≥2 in males) and/or bleeding (HAS-BLED score ≥3); contraindication to oral anticoagulation; refusal of oral anticoagulation despite informed consent
- Able to understand and sign informed consent
- Aged over 18 years
You will not qualify if you...
- Reversible causes of atrial fibrillation such as thyroid disorders, recent major surgery, trauma, or acute alcoholic intoxication
- Presence of other arrhythmias including atrial flutter or ventricular tachycardia
- Previous atrial fibrillation surgery or catheter ablation
- Previous cardiac surgery including valve replacement or septal repair
- Major cardiovascular events within the last 3 months including acute myocardial infarction or ventricular fibrillation
- History of congenital heart disease
- Previous atrioventricular node ablation
- History of lung lobectomy
- Other diseases with life expectancy less than 1 year
- Women with childbearing potential
- Participation in other interventional clinical trials that may affect prognosis
- Unable to understand or give informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200072
Actively Recruiting
Research Team
D
Dongdong Zhao
CONTACT
Z
Zhongyuan Ren
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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