Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

Atrial Fibrillation, Persistent Clinical Trial

Official title:

Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883722
• Other study ID #: KS(Y)23218
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.

Description:

Long-term persistent atrial fibrillation (PerAF) may induce right atrial (RA) enlargement and subsequently atrial functional tricuspid regurgitation (AF-TR) at the absence of structural valvular lesion, abnormal right ventricular geometry and function. Enlarged RA and significant AF-TR may aggravate atrial remodeling and contribute to AF sustaining. Previous studies showed that RA enlargement was closely related to the recurrence of AF after catheter ablation. However, unlike the left atrium, the RA mechanism has been poorly studied and generally excluded from the therapeutic target. In an animal model of right heart disease, the RA enlargement associated with re-entrant activity serves as the prominent mechanism of AF genesis. Using sophisticated mapping techniques, recent study has confirmed that up to one-third of AF drivers are located in the right atrium. Furthermore, our previous case report also showed that the majority of patients with right atrial appendage-driven AF have concomitant RA enlargement. Therefore, it is plausible to hypothesize that the presence of RA enlargement represents the necessity of adjunctive RA ablation. Currently, the value and timing of RA intervention are still under debate. Therefore, the purpose of the present study was to testify whether patients with PerAF and RA enlargement may benefit from adjunctive RA ablation

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines;

• Ineffective or intolerable to =1 anti-arrhythmia drug treatment.

Exclusion Criteria:

• Uncontrolled congestive heart failure;

• History of severe valve disease and/or prosthetic valve replacement;

• Myocardial infarction or stroke within 6 months;

• Severe congenital heart disease;

• EF <40%;

• Contrast agent allergy;

• The use of anticoagulant drugs is contraindicated;

• Severe lung disease;

• Left atrial thrombus confirmed by preoperative esophageal ultrasound;

• Contraindications for cardiac catheterization;

• Atrial fibrillation ablation;

• Have performed any cardiac surgery within 2 months;

• Poor general health;

• Life expectancy < 6 months.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

Procedure:
• Catheter ablation
The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Xu Liu	The Third Xiangya Hospital of Central South University, Yangpu District Central Hospital Affiliated to Tongji University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation recurrence	any AF episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 12 months after a single procedure.	12 months
Secondary	Atrial fibrillation/atrial tachycardia recurrence	any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs treatment at 12 months after a single procedure or freedom from any AF episodes lasting more than 30 seconds occurring after the blanking period without the use of anti-arrhythmic drugs at the end of study follow-up after a single procedure.	12 months