Advance Cardiac Resynchronization Therapy (CRT) Registry
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/6/2017 |
Start Date: | January 2013 |
End Date: | September 2017 |
Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders
The intent of this registry is to understand comprehensive clinical care strategies for
Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world
clinical practice.
Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world
clinical practice.
Patients who are implanted CRT devices will be enrolled in the study. Once implanted, all
patients will be followed at every 3 months for the first 12 months from the implant. The
responder/non-responder evaluation will occur at 6 months from the implant date. The criteria
used for determining the response to CRT will be captured.
During the office follow-up visits, arrhythmic episode diagnoses, device data and stored
electrogram will be collected. All clinical events such as hospitalization for HF, all-cause
hospitalizations, and all-cause death will also be collected. For patients who are
non-responders to CRT, any re-optimization of the device, i.e., AV/VV interval optimization,
LV lead repositioning and pacing vector reconfiguration as well as modified/new clinical
therapies administered in an attempt to improve HF condition will be collected.
patients will be followed at every 3 months for the first 12 months from the implant. The
responder/non-responder evaluation will occur at 6 months from the implant date. The criteria
used for determining the response to CRT will be captured.
During the office follow-up visits, arrhythmic episode diagnoses, device data and stored
electrogram will be collected. All clinical events such as hospitalization for HF, all-cause
hospitalizations, and all-cause death will also be collected. For patients who are
non-responders to CRT, any re-optimization of the device, i.e., AV/VV interval optimization,
LV lead repositioning and pacing vector reconfiguration as well as modified/new clinical
therapies administered in an attempt to improve HF condition will be collected.
Inclusion Criteria:
- Patient willing and able to sign informed consent
- Patients implanted with any market-approved St. Jude Medical CRT-D/P device with no
prior LV lead placement
Exclusion Criteria:
- Are likely to undergo heart transplantation within the next 12 months
- Are less than 18 years of age
- Are pregnant or planning to become pregnant during the duration of the study
- Are currently participating in a clinical investigation that includes an active
treatment arm
- Have a life expectancy of less than 6 months
We found this trial at
42
sites
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Genesis Healthcare System Genesis HealthCare System is an integrated health care delivery system based in...
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