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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: Completed NA study of Bradycardia and Slow Heart Beat, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2007-02 |
| Est. Completion | 2010-08 |
| Phase | NA |
What the finished NCT00433654 record still lists
NCT00433654 is an interventional study that assigns participants to a tested intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap, below the 4,396-participant average among 29 other Bradycardia trials with a reported enrollment target (89% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00433654's enrollment target sits among peer trials
484 17th of 29 higher than 13 of 29 other Bradycardia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bradycardia 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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