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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Cardiology, Shanghai Tenth People's Hospital
RECRUITING
Shanghai
Contact Information
Primary
Dongdong Zhao
zhaodd@tongji.edu.cn
+86 18917684008
Backup
Zhongyuan Ren
2111714@tongji.edu.cn
+86 18862186450
Time Frame
Start Date: 2021-11-10
Estimated Completion Date: 2027-11-10
Participants
Target number of participants: 100
Treatments
Combined procedure
The whole cohort underwent combining procedure of catheter ablation and left atrial appendage closure, atrial pressure was measured before and after pulmonary vein isolation, and after left atrial appendage closure.
Sponsors
Leads: Shanghai 10th People's Hospital

This content was sourced from clinicaltrials.gov