Measuring Heart Chamber Pressure Around a Combined Atrial Fibrillation Procedure
Observes heart pressure changes in adults with atrial fibrillation undergoing a combined heart procedure.
Plain-language title generated from the registry record
Registry title: The Impact of Atrial Pressure Change Before and After Combined Procedure
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Department of Cardiology, Shanghai Tenth People's HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai 10th People's Hospital
- Trial code
- NCT05106270
- Record updated
- 2 September 2022
- Original description
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.Read full original descriptionShow less
The Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation
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.
Inclusion: Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; Eligible for left atrial appendage closure, that meet at least one of the followings:; At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3); Contraindicated to oral anticoagulation (OAC); Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment; Capable of understanding and signing the informed consent form; Aged over 18 years.
Exclusion: Concomitant arrhythmia including atrial flutter, ventricular tachycardia; A previous history of atrial fibrillation surgery (MAZE surgery) or catheter ablation; A previous history of cardiac surgery including any valvular replacement, septal repair; A previous history of atrioventricular node ablation; Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication; A recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation; A history of congenital heart disease; A history of lobectomy due to any medical condition; Complicated by other diseases with life expectation <1 year; Women with childbearing potential; Participated in other interventional clinical trials that might affect prognosis; Unable to understand or give informed consent form.