Evaluation of Left Ventricular Autothreshold, Phase Two

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT01242722
Run by: Boston Scientific Corporation
People needed: 100
Starts: 2010-11-01
Expected to finish: 2011-03-01
Last updated by the study team: 2012-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Regional Cardiovascular Medical Center — Stuebenville, Ohio, United States

Full record on ClinicalTrials.gov

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