NCT05106270Recruiting
The Impact of Atrial Pressure Change Before and After Combined 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
Source: ClinicalTrials.gov · Last updated 2 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 20 Sept 2021
- Start date
- 10 Nov 2021
- Primary completion date
- 10 Nov 2023
- Lead sponsor
- Shanghai 10th People's Hospital
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT05106270
What you commit to
- Study type: Observational
- Planned participants: 100
- From 10 Nov 2021 to the primary completion date, 10 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 previous history of atrioventricular node ablation;
Other illness
- Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication;
- A recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation;
- A history of congenital heart disease;
- A history of lobectomy due to any medical condition;
- Complicated by other diseases with life expectation \<1 year;
Other
- Women with childbearing potential;
- Participated in other interventional clinical trials that might affect prognosis;
- Unable to understand or give informed consent form.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology, Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.