Evaluation of Left Ventricular AutoThreshold

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00812201

Acronym

ELEVATE

Enrollment

Registered

2008-12-22

Start date

2008-12-31

Completion date

2009-10-31

Last updated

2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, auto threshold, pacing, CRT-P or CRT-D recipients, threshold measurements

Brief summary

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

Detailed description

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.

Interventions

DEVICENo intervention is used. Collection of signals only.

Device received per standard of care.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The objective of this study is to collect data to characterize the performance of the LVAT feature.	Implant

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026