Evaluation of Left Ventricular Autothreshold, Phase Two (ELEVATE 2)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT01242722

First received: November 12, 2010

Last updated: October 2, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 12, 2010

Last Updated Date

October 2, 2012

Start Date ^ICMJE

November 2010

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing [ Time Frame: At least 24 hours post CRT-D implant ] [ Designated as safety issue: No ]

The primary objective of this study is to collect real-time signals during LV pacing voltage step-down from patients with implanted COGNIS CRT-D devices in a follow-up setting. This data will be used to assess the stability of the LV evoked response electrogram signal and will be used in an offline assessment of the LVAT algorithm. One or two data points will be collected per patient in the trial. Patients must be at least 24 hours post implant of their COGNIS CRT-D device

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01242722 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Left Ventricular Autothreshold, Phase Two

Official Title ^ICMJE

Evaluation of Left Ventricular Autothreshold, Phase Two

Brief Summary

This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.

Detailed Description

ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The study population will be a sample of patients with COGNIS CRT-D devices and bipolar LV leads.

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Device: CRT-D

Cardiac pacing via a pulse generator and implanted intracardiac leads

Study Group/Cohort (s)

Two experimental and/or intervention groups under 1 arm.

Intervention: Device: CRT-D

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without a right atrial lead
Patients who have an active LV bipolar lead
Patients who have an active right ventricular (RV) defibrillation lead
Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
Patients who are pacemaker-dependent
Patients who will not tolerate a pacing pause of up to 6 seconds
Patients who have a unipolar LV pace/sense lead, 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
Patients with a pre-existing unipolar pacemaker
Patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes
Patients enrolled in any concurrent study, without Boston Scientific written approval
Women who are pregnant

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01242722

Other Study ID Numbers ^ICMJE

ELEVATE 2.0

Has Data Monitoring Committee

Responsible Party

Boston Scientific Corporation

Study Sponsor ^ICMJE

Boston Scientific Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kenneth L Ellenbogen, M.D.

Virginia Commonwealth University Health System

Information Provided By

Boston Scientific Corporation

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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