The Impact of Atrial Pressure Change Before and After Combined Procedure

Recruiting now

Conditions studied: Atrial Fibrillation, Heart Failure

In brief

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.

Key facts

Study ID

NCT05106270

Run by

Shanghai 10th People's Hospital

People needed

100

Starts

2021-11-10

Expected to finish

2027-11-10

Last updated by the study team

2022-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication;
• 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 recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation;
• A history of congenital heart disease;
• A previous history of atrioventricular node ablation;
• 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.

Where it is running

• Department of Cardiology, Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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