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The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

NCT02030418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 952

Last updated 2025-07-09

Study results available
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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.

Conditions

  • Bradycardia

Interventions

DEVICE

Leadless Pacemaker

Patients will undergo an attempted leadless pacemaker implant

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Vivik Reddy, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-06-30
Completion
2022-07-15
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

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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 NCT02030418 on ClinicalTrials.gov