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NCT01168427 · ClinicalTrials.gov registry record

Reveal In-Office Implants

A clinical trial, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

Completed
Registry status
66
Enrollment target

NCT01168427: Completed study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

NCT01168427 is a clinical trial that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 66 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01168427 has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

COMPLETED
Registry status
66 participants
Enrollment target

Study Summary

The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (EP) laboratory setting.

Primary Outcome

This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.

Interventions

  • DEVICE Reveal® DX or Reveal® XT Insertable Cardiac Monitor

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2010-08
Est. Completion 2011-05

What the finished NCT01168427 record still lists

NCT01168427 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 66 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Reveal® DX or Reveal® XT Insertable Cardiac Monitor is the first listed.

NCT01168427 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01168427 about?

NCT01168427 is a clinical study titled "Reveal In-Office Implants". The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (EP) l...

What is the current status of trial NCT01168427?

This trial is currently completed. The enrollment target is 66 participants. The study started on 2010-08. Estimated completion is 2011-05.

What interventions are being tested in trial NCT01168427?

The interventions under investigation include: Reveal® DX or Reveal® XT Insertable Cardiac Monitor (DEVICE).

Who is sponsoring clinical trial NCT01168427?

This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01168427, the US trial registry maintained by the National Library of Medicine. NCT01168427 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.