Evaluation of Left Ventricular Autothreshold, Phase Two (NCT01242722) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Left Ventricular Autothreshold, Phase Two
United States100 participantsStarted 2010-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
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
* 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
What they're measuring
1
Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing