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EMRI SureScan™ Clinical Study
NCT00433654 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00433654
The ClinicalTrials.gov registry entry for NCT00433654 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00433654 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00433654?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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