CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 217 enrolled
Drug / intervention
Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)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/NCT00311181
NCT00311181Phase 4Completed
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Phase 4 Study That Compares the DFT (Defibrillation Threshold) Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms

Abbott Medical Devices·interventional·Posted Apr 5, 2006·Updated Feb 20, 2019

In Brief

A Phase 4 clinical trial evaluating Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D) for Sudden Cardiac Death. Completed, enrolled 217 participants across 2 sites.

Detailed Summary

The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant based biphasic defibrillation waveforms. This comparison will result in identifying the optimal membrane time constant when programming the "tuned" defibrillation waveform.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSudden Cardiac Death
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 5, 2006
Enrollment StartAug 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.2 years ago

Interventions

Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)device

Patients that are indicated for an ICD or CRT-D receive one of these devices.