CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 442 enrolled
Drug / intervention
Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00354159
NCT00354159N/ACompleted
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Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic HF (REDUCEhf)

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Jul 20, 2006·Updated Aug 9, 2012

In Brief

A clinical study evaluating Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD) for Heart Failure. Completed, enrolled 442 participants across 52 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 20, 2006
Enrollment StartApr 1, 2006
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.9 years ago

Interventions

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

Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.