Measuring Atrial Pressure Changes During a Combined Heart Procedure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to measure the changes in left and right atrial pressure before and after a combined procedure involving catheter ablation and left atrial appendage closure in patients with atrial fibrillation. The study will recruit patients who are at high risk of stroke or bleeding and are eligible for the procedure. The researchers will investigate how these pressure changes affect clinical outcomes, particularly in relation to heart failure progression. The methodology includes using transseptal puncture to measure atrial pressures during the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
  2. Contraindicated to oral anticoagulation (OAC);
  3. 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 Criteria:

* 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's running

• Department of Cardiology, Shanghai Tenth People's Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yawei Xu — Shanghai 10th People's Hospital
• Study coordinator: Dongdong Zhao
• Email: zhaodd@tongji.edu.cn
• Phone: +86 18917684008

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.