Measuring Atrial Pressure Changes During a Combined Heart Procedure

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

This study is testing how changes in heart pressure during a combined procedure can affect the health of patients with atrial fibrillation who are at high risk for stroke or bleeding.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai 10th People's Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05106270 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with atrial fibrillation who are at high risk of stroke or bleeding and are eligible for left atrial appendage closure.

Not a fit: Patients with reversible causes of atrial fibrillation or those who have had previous cardiac surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into managing atrial pressure changes, potentially improving outcomes for patients undergoing combined procedures for atrial fibrillation.

How similar studies have performed: While there have been studies on catheter ablation and left atrial appendage closure separately, this specific investigation into atrial pressure changes during a combined procedure is novel.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions: Atrial Fibrillation, Heart Failure, Left atrial pressure, combined procedure, Catheter ablation, Left atrial appendage closure, Cardiac function