NCT05106270 The Impact of Atrial Pressure Change Before and After Combined Procedure
| NCT ID | NCT05106270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai 10th People's Hospital |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-11-10 |
| Primary Completion | 2023-11-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-11-10 with a primary completion date of 2023-11-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Yawei Xu
PRINCIPAL INVESTIGATOR
Shanghai 10th People's Hospital
Frequently Asked Questions
Who can join the NCT05106270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05106270 currently recruiting?
Yes, NCT05106270 is actively recruiting participants. Contact the research team at zhaodd@tongji.edu.cn for enrollment information.
Where is the NCT05106270 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05106270 clinical trial?
NCT05106270 is sponsored by Shanghai 10th People's Hospital. The principal investigator is Yawei Xu at Shanghai 10th People's Hospital. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.