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ASCEND CSP IDE Study

NCT06830746 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2026-03-18

No results posted yet for this study

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

Interventions

DEVICE

LBBAP Implant with a CSP ICD Lead

Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2026-01-29
Completion
2028-05-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Hong Kong
  • India
  • Italy
  • Singapore
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830746 on ClinicalTrials.gov