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NCT00354159 · ClinicalTrials.gov registry record · NA
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
A NA study of Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 442
- Enrollment target
- 20
- Study locations
NCT00354159: Completed NA study of Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT00354159 is a NA study of Heart Failure that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 442 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00354159, a NA study of Heart Failure, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 442 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.
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
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2006-04 |
| Est. Completion | 2011-01 |
| Phase | NA |
What the finished NCT00354159 record still lists
NCT00354159 is an interventional study that assigns participants to a tested intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (78% lower).
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.
NCT00354159 names 20 study sites across 10 states, led by California, Massachusetts, Michigan.
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.
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).
Who is sponsoring clinical trial NCT00354159?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT00354159's enrollment target sits among peer trials
442 113th of 397 higher than 285 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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