Clinical trial NCT05883722: Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation
Official title: Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Keywords: catheter ablation
atrial fibrillation
Driver ablation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: The Third Xiangya Hospital of Central South University
name: Yangpu District Central Hospital Affiliated to Tongji University
First posted: 2023-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Atrial fibrillation recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Atrial fibrillation/atrial tachycardia recurrence
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: