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NCT01576016 · ClinicalTrials.gov registry record · NA

Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead

A NA study, sponsored by Abbott Medical Devices.

Completed
Registry status
NA
Development phase
950
Enrollment target

NCT01576016: Completed NA study, sponsored by Abbott Medical Devices.

NCT01576016 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 950 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01576016, a NA study, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
NA
Development phase
950 participants
Enrollment target

Study Summary

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

Primary Outcome

Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit

Interventions

  • DEVICE Accent MRI system (lead safety)
  • DEVICE Accent MRI system (with MRI scan)

Trial Details

FieldValue
Enrollment Target 950 participants
Start Date 2012-03-30
Est. Completion 2018-02-02
Phase NA
Abbott Medical Devices

261 total trials

What the finished NCT01576016 record still lists

NCT01576016 is an interventional study that assigns participants to a tested intervention. The registered 950 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 2 interventions - of which Accent MRI system (lead safety) is the first listed.

NCT01576016 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01576016 about?

NCT01576016 is a clinical study titled "Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead". The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

What is the current status of trial NCT01576016?

This trial is currently completed. It is a NA study. The enrollment target is 950 participants. The study started on 2012-03-30. Estimated completion is 2018-02-02.

What interventions are being tested in trial NCT01576016?

The interventions under investigation include: Accent MRI system (lead safety) (DEVICE), Accent MRI system (with MRI scan) (DEVICE).

Who is sponsoring clinical trial NCT01576016?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01576016's enrollment target sits among peer trials

950 123rd of 2000 higher than 1,878 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01576016, the US trial registry maintained by the National Library of Medicine. NCT01576016 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.