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InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry

NCT00273182 · View on ClinicalTrials.gov ↗

Study Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart. The purpose of this study is to monitor the long-term performance of the InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy (CRT).

Interventions

  • DEVICE InSync Model 8040
  • DEVICE InSync III Model 8042

Study Locations (20)

Florida

  • — Gainesville
  • — Jacksonville
  • — Jupiter
  • — Melbourne
  • — Miami
  • — Orlando
  • — Tampa

California

  • — Long Beach
  • — Napa
  • — Oxnard
  • — San Diego
  • — Yuba City

Arkansas

  • — Fort Smith
  • — Little Rock

Illinois

  • — Rockford
  • — Springfield

Alabama

  • — Birmingham

Arizona

  • — Peoria

District of Columbia

  • — Washington D.C.

Georgia

  • — Atlanta

Trial Details

FieldValue
Enrollment Target 1,999 participants
Start Date 2002-03
Est. Completion 2011-04

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00273182

The ClinicalTrials.gov registry entry for NCT00273182 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 1,999 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 Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which InSync Model 8040 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: NCT00273182 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Arkansas. 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 NCT00273182 about?

NCT00273182 is a clinical study titled "InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry". Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the hea...

What is the current status of trial NCT00273182?

This trial is currently completed. The enrollment target is 1,999 participants. The study started on 2002-03. Estimated completion is 2011-04.

What conditions does trial NCT00273182 study?

This clinical trial studies the following conditions: Heart Failure, Cardiomyopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00273182?

The interventions under investigation include: InSync Model 8040 (DEVICE), InSync III Model 8042 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00273182?

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 NCT00273182 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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