Evaluation of Left Ventricular AutoThreshold

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-10-31

Brief Summary

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This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

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Detailed Description

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ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No intervention is used. Collection of signals only.

Intervention Type DEVICE

Device received per standard of care.

Interventions

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No intervention is used. Collection of signals only.

Device received per standard of care.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
* Patients who are willing and capable of participating in all testing associated with this study
* Patients who are 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria

* Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
* Patients with pre-existing leads other than those specified in this investigational plan (unless the Investigator intends to replace them with permitted leads)
* Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
* Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
* Patients with a prosthetic mechanical tricuspid heart valve
* Women who are pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No