The Impact of Atrial Pressure Change Before and After Combined Procedure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months;
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Atrial pressure measurement using transseptal puncture sheath
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov