NCT05125159

Angioplasty Guidewire-Assisted Versus Conventional Transseptal Puncture for Left Atrial Appendage Occlusion

Randomized Trial of Angioplasty Guidewire-Assisted Transseptal Puncture Technique Versus Conventional Technique for Left Atrial Access in Left Atrial Appendage Occlusion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, single-blinded, three-center, randomized, controlled trial comparing the effectiveness and safety of angioplasty guidewire-assisted transseptal puncture (GW-TSP) technique to transseptal left atrial (LA) access with conventional transseptal puncture with standard transseptal equipment (CON-TSP) in patients undergoing left atrial appendage occlusion (LAAO) procedure for atrial fibrillation. The targeted population will consist of patients with atrial fibrillation undergoing LAAO.

Detailed description

Transseptal catheterization is a critical step for left atrial interventions (atrial fibrillation ablation, LA appendage closure, mitral valve interventions). The availability of suitable tools and techniques is essential to safely perform the TSP, effectively deliver radiofrequency lesions, deploy LA devices, and anticipate difficult procedural situations in which complications may arise. Historically, a conventional Brockenbrough (BRK) needle has been used for this procedure to mechanically puncture the fossa ovalis, which has been well described in the literature. Although generally safe, serious complications such as perforation of the atrial wall or aorta can occur. This study is intended to assess the safety, performance and usability of the angioplasty guidewire in facilitating access to the left atrium during LAAO procedures for the treatment of atrial fibrillation (AF). Moreover, the study will assess the impact of the GW-TSP on procedural times, including time to achieve left atrial accesses, total procedure times, total fluoroscopy time. The study is a prospective, single-blinded, three-center, randomized, controlled trial. Enrolled subjects who meet the study inclusion/exclusion criteria will be evaluated during the LAAO procedures and followed until release from hospital post procedure per institutional standard of care. After 30 days, patient will be contacted by telephone to obtain information on their clinical condition and any adverse events; if necessary, a clinic visit may be performed when required by the physician.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture	Patients randomized to the angioplasty guidewire-assisted transseptal puncture (GW-TSP) group will undergo transseptal puncture with angioplasty guidewire-assistance. Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with BRK needle (St. Jude Medical).

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: China