ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0

NCT01539629 | Completed

• 1 other identifier: ELEVATE 3.0
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Failure

Keywords

Heart failure; Autothreshold; Pacing; CRT-D recipients; Left Ventricular evoked response signals

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Pulse Width

One group reflecting two different pulse widths.

Device: Cardiac pacing

Interventions

Cardiac pacing DEVICE

Cadiac pacing via a pulse generator and implaned intracardiac leads.

Also known as: COGNIS PG.

Pulse Width

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, 19067, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23298-0053, United States

Location

Wheaton Franciscan Health Care

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kenneth L Ellenbogen, MD

  Virginia Commonwealth University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: February 27, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-10

Locations

US (4)