Exclusion of the left atrial appendage in Chinese population with perclip system: 1-year follow-up outcome results from a prospective, multi-center, open-label, single-arm device trial.

BACKGROUND

Atrial fibrillation (AF) significantly increases stroke risk, particularly through left atrial appendage (LAA) involvement. This trial evaluated the safety and efficacy of the Perclip system for LAA exclusion in Chinese AF patients.

METHODS

This prospective study recruited patients with AF and CHA2DS2-VASc scores ≥ 2 who required conventional concomitant open-heart surgery or AF surgery through thoracoscopy at nine centers in China. The Perclip LAA occlusion system was implanted during surgery and follow-ups were scheduled at 30 days and 3, 6, and 12 months after surgery. The primary efficacy endpoint was the complete LAA closure rate at 3 months after surgery. The primary safety endpoint was the incidence of device-related serious adverse events within 30 days after surgery.

RESULTS

Perclip implantation was performed on 76 participants (concomitantly with open-heart surgery in 65 participants). The device was successfully implanted in all subjects. The complete LAA closure rate was 98.7% (75/76) at 30 days and 100% (75/75) at 3 months post-surgery. The incidence of device-related serious adverse events within 30 days after surgery was 1.3% (1/76). One participant, who underwent left atrial plication and LAA occlusion, developed an atrial thrombus. Additionally, there were no cases of cardiovascular death, cardiac structural damage, myocardial infarction, major bleeding, stroke, or non-central nervous system embolism within 12 months post-surgery.

CONCLUSIONS

This 1-year multicenter trial supports the efficacy and safety of the Perclip system for LAA exclusion in Chinese AF patients. Long-term follow-up will provide additional insights into the outcomes of the Perclip system.

TRIAL REGISTRATION: This trial was retrospectively registered on the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) on January 31, 2024.

REGISTRATION NUMBER: ChiCTR2400080521.