NCT02030418

The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 952 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker. Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.

Detailed description

The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	Leadless Pacemaker	Patients will undergo an attempted leadless pacemaker implant

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-06-01
• Completion: 2022-07-15
• First posted: 2014-01-08
• Last updated: 2025-07-09
• Results posted: 2025-07-09

Locations

59 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated device study