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Clinical trial

The LEADLESS Pacemaker IDE Study (Leadless II)

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Last updated:1st Feb 2014

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.

Study Type: Interventional
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
Estimated Enrollment: 667
Study Start Date: February 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

- Experimental:
Leadless Pacemaker

Related journal: Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker

Category Value
Study start date 2014-02-01

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