NCT06830746

ASCEND CSP IDE Study

A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy. The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.

Conditions

• Heart Failure
• Ventricular Arrythmia

Interventions

Type	Name	Description
DEVICE	LBBAP Implant with a CSP ICD Lead	Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Timeline

• Start date: 2025-04-11
• Primary completion: 2026-01-29
• Completion: 2028-05-01
• First posted: 2025-02-17
• Last updated: 2026-03-18

Locations

37 sites across 10 countries: United States, Australia, Canada, France, Hong Kong, India, Italy, Singapore, Spain, Switzerland

Regulatory

• FDA-regulated device study