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NCT00433654 · ClinicalTrials.gov registry record · NA

EMRI SureScan™ Clinical Study

A NA study of Bradycardia and Slow Heart Beat, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

Completed
Registry status
NA
Development phase
484
Enrollment target
20
Study locations

NCT00433654 is a NA study of Bradycardia and Slow Heart Beat that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 484 participants, below the 4,396-participant average among 29 other Bradycardia trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00433654, a NA study of Bradycardia and Slow Heart Beat, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

COMPLETED
Registry status
NA
Development phase
484 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

Conditions Studied

Bradycardia Slow Heart Beat

Interventions

  • DEVICE Implantable Pulse Generator (IPG) and Pacing Leads (wires)
  • OTHER Magnetic Resonance Imaging (MRI) scan

Study Locations (20)

Other

  • - Graz
  • - Linz
  • - Liège
  • - Mons

California

  • - Redwood City
  • - Salinas

Missouri

  • - Kansas City
  • - St Louis

Ohio

  • - Cincinnati
  • - Cleveland

Virginia

  • - Charlottesville
  • - Norfolk

Florida

  • - Orlando

Georgia

  • - Peachtree City

Iowa

  • - Des Moines

Trial Details

FieldValue
Enrollment Target 484 participants
Start Date 2007-02
Est. Completion 2010-08
Phase NA

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

115 total trials

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What the Registry Record Tells You About NCT00433654

The ClinicalTrials.gov registry entry for NCT00433654 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,396-participant average among 29 other Bradycardia trials with a reported enrollment target (89% lower). The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Bradycardia appearing as the primary indexed condition, and to 2 interventions - of which Implantable Pulse Generator (IPG) and Pacing Leads (wires) is the first listed.

NCT00433654 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Missouri.

Frequently Asked Questions

What is clinical trial NCT00433654 about?

NCT00433654 is a clinical study titled "EMRI SureScan™ Clinical Study". The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

What is the current status of trial NCT00433654?

This trial is currently completed. It is a NA study. The enrollment target is 484 participants. The study started on 2007-02. Estimated completion is 2010-08.

What conditions does trial NCT00433654 study?

This clinical trial studies the following conditions: Bradycardia, Slow Heart Beat.

What interventions are being tested in trial NCT00433654?

The interventions under investigation include: Implantable Pulse Generator (IPG) and Pacing Leads (wires) (DEVICE), Magnetic Resonance Imaging (MRI) scan (OTHER).

Who is sponsoring clinical trial NCT00433654?

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

Where is trial NCT00433654 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Iowa, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.