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COMPLETED NA

Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)

NCT00354159 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to record and report the force with which the heart pumps blood (heart pressures). When combined with the ICD, the device has the additional ability to send a strong electrical impulse, or shock, to the heart when it detects dangerously fast heartbeats to return it to a normal rhythm. The IHM and IHM/ICD are implanted surgically just under the skin in the upper chest area. This study will also determine how doctors use the information related to heart pressures in the management of heart failure.

Conditions Studied

Interventions

  • DEVICE Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)

Study Locations (20)

California

  • Scripps Green Hospital — La Jolla
  • Loma Linda University Medical Center — Loma Linda
  • Long Beach Memorial — Long Beach
  • Cedars-Sinai Medical Center — Los Angeles
  • Doctors Medical Center Modesto — Modesto

Massachusetts

  • Brigham & Women's Hospital — Boston
  • Lahey Clinic Medical Center — Burlington
  • University of Massachusetts Memorial Medical Center — Worcester

Michigan

  • St Joseph Mercy Hospital — Ann Arbor
  • University of Michigan — Ann Arbor
  • Henry Ford Hospital — Detroit

Florida

  • University of FL Shands — Gainesville
  • Mayo Clinic Jacksonville — Jacksonville

Iowa

  • Genesis Hospital Midwest Cardiovascular Research Foundation — Davenport
  • Iowa Heart Center — West Des Moines

Alabama

  • University of Alabama at Birmingham (UAB) — Birmingham

Connecticut

  • Yale University, School of Medicine — New Haven

Delaware

  • Christiana Care Hospital — Newark

Trial Details

FieldValue
Enrollment Target 442 participants
Start Date 2006-04
Est. Completion 2011-01
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00354159

The ClinicalTrials.gov registry entry for NCT00354159 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 442 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 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD) 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: NCT00354159 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Massachusetts, Michigan. 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 NCT00354159 about?

NCT00354159 is a clinical study titled "Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)". The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to record and report the f...

What is the current status of trial NCT00354159?

This trial is currently completed. It is a NA study. The enrollment target is 442 participants. The study started on 2006-04. Estimated completion is 2011-01.

What conditions does trial NCT00354159 study?

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

What interventions are being tested in trial NCT00354159?

The interventions under investigation include: Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00354159?

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 NCT00354159 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Delaware, Florida. 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