Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis

Persistent Atrial Fibrillation Clinical Trial

Official title:

A Single-arm Study to Evaluate the Efficacy and Safety of Left Atrial Isolation Achieved by Catheter Ablation in Patients With Persistent Atrial Fibrillation and Severe Atrial Fibrosis: a Chinese Registry Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05173779
• Other study ID #: LAICA
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: Shanghai Chest Hospital
• Contact: Mu Qin, M.D.
• Phone: +8613052320103
• Email: qinmuae[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Description:

This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged 18 to 80 years old

2. Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter > 50mm

3. Nonresponse or intolerance to =1 antiarrhythmic drug

4. CHA2DS2-VASc = 3 and HAS-BLED < 3

Exclusion Criteria:

1. With uncontrolled congestive heart failure;

2. Having significant valvular disease;

3. Having moderate-to-severe pulmonary hypertension;

4. With myocardial infarction or stroke within 6 months of screening;

5. With Significant congenital heart disease;

6. Ejection fraction was <40% measured by echocardiography;

7. Allergic to contrast media;

8. Contraindication to anticoagulation medications;

9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

10. Left atrial thrombus;

11. Having any contraindication to right or left sided heart catheterization

Related Conditions & MeSH terms

• Atrial Fibrillation
• Fibrosis
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Left atrial isolation by catheter ablation
Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate	AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration	up to 18 months after enrollment
Secondary	Postoperative AF recurrence rate	AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration	up to 18 months after enrollment
Secondary	Postoperative AFL/AT rate	Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration	up to 18 months after enrollment
Secondary	Incidence of complications	including death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding	up to 18 months after enrollment
Secondary	Changes in the diameter of the left atrium and the left ventricular ejection fraction		up to 18 months after enrollment