Evaluation of Left Ventricular Autothreshold, Phase Two

NCT01242722 | Completed

• 1 other identifier: ELEVATE 2.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; auto threshold; pacing; CRT-D recipients; Left Ventricular (LV) evoked response signals

Outcome Measures

Primary Outcomes (1)

• Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing

  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

  At least 24 hours post CRT-D implant

Study Arms (1)

1

Two experimental and/or intervention groups under 1 arm.

Device: CRT-D

Interventions

CRT-D DEVICE

Cardiac pacing via a pulse generator and implanted intracardiac leads

1

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 and bipolar LV leads.

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Regional Cardiovascular Medical Center

Stuebenville, Ohio, 43952, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kenneth L Ellenbogen, M.D.

  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: November 12, 2010
• First Posted: November 17, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

US (1)