Heart Failure
Conditions
Keywords
Heart failure, Autothreshold, Pacing, CRT-D recipients, Left Ventricular evoked response signals
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.
Interventions
DEVICECardiac pacing
Cadiac pacing via a pulse generator and implaned intracardiac leads.
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing. | Minimum of 24 hrs post CRT-D implant. | 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. |
Countries
United States
Outcome results
None listed