Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.

Persistent Atrial Fibrillation Clinical Trial

Official title:

A Randomized Control Study of Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05085912
• Other study ID #: DAAF
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: October 2021
• 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 an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Description:

This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 31, 2024
• Est. primary completion date: October 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;

3. Nonresponse or intolerance to =1 antiarrhythmic drug.

Exclusion Criteria:

1. With uncontrolled congestive heart failure;

2. Having significant valvular disease;

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

4. With Significant congenital heart disease;

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

6. Allergic to contrast media;

7. Contraindication to anticoagulation medications;

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

9. Left atrial (LA) thrombus;

10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

12. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Fibrosis
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.
• Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.
• Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.

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 12 months after ablation
Primary	Intraoperative AF termination rate	AF termination is defined as conversion to sinus rhythm or stable AFL/AT.	through ablation completion, an average of 3 hours
Secondary	Postoperative AF recurrence rate	AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration	up to 12 months after ablation
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 12 months after ablation
Secondary	Incidence of complications	death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding	up to 12 months after ablation
Secondary	Changes in the diameter of the left atrium	Changes in the diameter of the left atrium	up to 12 months after ablation
Secondary	Changes in the left ventricular ejection fraction	Changes in the left ventricular ejection fraction	up to 12 months after ablation