Status:
COMPLETED
Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Northwestern University
VA Pittsburgh Healthcare System
Conditions:
Heart Failure
Ventricular Arrhythmias
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to deter...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00996086
Start Date
February 1 2010
End Date
September 1 2012
Last Update
February 4 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Touro College
New York, New York, United States, 10010
2
Veterans' Adminstration Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240