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NCT00273182 · ClinicalTrials.gov registry record

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

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

Completed
Registry status
1,999
Enrollment target
20
Study locations

NCT00273182: Completed study of Heart Failure and Cardiomyopathy, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

NCT00273182 is a study of Heart Failure and Cardiomyopathy that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 1,999 participants, roughly in line with the 2,044-participant average among 397 other Heart Failure trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00273182, a study of Heart Failure and Cardiomyopathy, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

COMPLETED
Registry status
1,999 participants
Enrollment target
20
Study locations

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).

Primary Outcome

Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules

Conditions Studied

Heart Failure Cardiomyopathy

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
Medtronic Cardiac Rhythm and Heart Failure

115 total trials

What the finished NCT00273182 record still lists

NCT00273182 is an observational study that tracks outcomes without assigning an intervention. Its 1,999 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 2,044-participant average among 397 other Heart Failure trials with a reported enrollment target.

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.

NCT00273182 names 20 study sites across 8 states, led by Florida, California, Arkansas.

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.

What interventions are being tested in trial NCT00273182?

The interventions under investigation include: InSync Model 8040 (DEVICE), InSync III Model 8042 (DEVICE).

Who is sponsoring clinical trial NCT00273182?

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

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.

Learn More About Clinical Trials

Similar trials for Heart Failure

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 NCT00273182's enrollment target sits among peer trials

1,999 45th of 397 higher than 353 of 397 other Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure 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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Related registry views

Source: ClinicalTrials.gov NCT00273182, the US trial registry maintained by the National Library of Medicine. NCT00273182 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.