Evaluation of Left Ventricular AutoThreshold | NCT00812201

Studies
Evaluation of Left Ventricular AutoThreshold

NCT00812201

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Jun 28, 2022Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

No intervention is used. Collection of signals only.

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

Jun 2022

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

Dec 2008

Primary Completion Date

May 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Dec 18, 2008

First Submission Date that Met QC Criteria

Dec 19, 2008

First Posted Date

Dec 22, 2008Estimated

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

Jun 27, 2022

Last Update Posted Date

Jun 28, 2022Actual

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 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.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1			Device: No intervention is used. Collection of signals only.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention is used. Collection of signals only.	Device	Device received per standard of care.	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth L. Ellenbogen, M.D.	Virginia Commonwealth University Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University Health System		Richmond	Virginia	23298	United States
Monongalia General Hospital

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases