Evaluation of Left Ventricular AutoThreshold

Completed

Conditions studied: Heart Failure

In brief

This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

Key facts

Study ID

NCT00812201

Run by

Boston Scientific Corporation

People needed

80

Starts

2008-12-01

Expected to finish

2009-10-01

Last updated by the study team

2022-06-28

Who can join

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

You may qualify if…

• Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
• Patients who are willing and capable of participating in all testing associated with this study
• Patients who are 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, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, 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 (unless the Investigator intends to replace them with permitted leads)
• Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
• Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
• Patients with a prosthetic mechanical tricuspid heart valve
• Women who are pregnant

Where it is running

• Virginia Commonwealth University Health System — Richmond, Virginia, United States
• Monongalia General Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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