Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

Completed

Conditions studied: Heart Failure, Ventricular Arrhythmias

In brief

This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.

Key facts

Study ID

NCT00996086

Run by

Abbott Medical Devices

People needed

154

Starts

2010-02-01

Expected to finish

2012-09-01

Last updated by the study team

2019-02-04

Who can join

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

You may qualify if…

• Meets current clinical indications for CRT-D therapy
• Patient is 18 years old or older
• Ability to independently comprehend and complete all QOL questionnaires
• Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
• Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up

You may not qualify if…

• Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
• Myocardial infarction in the last 3 weeks
• Unstable angina in the last 3 weeks
• Status 1 classification for cardiac transplantation
• Currently participating in a clinical trial that includes an active treatment arm
• Life expectancy of less than 12 months.
• Recent (within 1 week) administration of Nesiritide™ or inotropes
• Patients in whom revascularization is expected
• Patient is pregnant

Where it is running

• Touro College — New York, New York, United States
• Veterans' Adminstration Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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