ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0 | NCT01539629

Studies
ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0

NCT01539629

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Dec 5, 2012Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Cardiac pacing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jun 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Feb 22, 2012

First Submission Date that Met QC Criteria

Feb 24, 2012

First Posted Date

Feb 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2012

Last Update Posted Date

Dec 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to evaluate a new feature for future heart failure devices.

Detailed Description

ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) feature.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulse Width		One group reflecting two different pulse widths.	Device: Cardiac pacing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac pacing	Device	Cadiac pacing via a pulse generator and implaned intracardiac leads.	Pulse Width

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.	The primary objective of this study is to collect real-time signals during LV pacing and voltage step-down from patients with implanted COGNIS devices.	Minimum of 24 hrs post CRT-D implant.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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 as defined as VVI 40 without intrinsic atrial or ventricular activity
Patients who will not tolerate a pacing pause of up to 6 seconds
Patients with a pre-existing unipolar pacemaker
Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
Patients enrolled in any concurrent study, without Boston Scientific CRM written approval
Women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth L Ellenbogen, MD	Virginia Commonwealth University Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Genesis Medical Center		Davenport	Iowa	52803	United States
Cardiology Consultants of Philadelphia

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases