This trial is active, not recruiting.

Condition heart failure
Treatment crt patients
Sponsor St. Jude Medical
Start date January 2013
End date December 2016
Trial size 1500 participants
Trial identifier NCT01805154, 60046199


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients who have received any market approved St Jude Medical CRT-D or CRT-P device
crt patients St Jude Medical, Any approved CRT device
This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.

Primary Outcomes

Rates of non-responders to CRT using 1) clinical composite score and 2) site-specific criteria for determining response to CRT
time frame: 6 months
Characterizing the types of symptom-based and objective definitions used by sites to determine patients' response to CRT
time frame: 6 months
Characterizing the treatment strategies employed by sites to treat HF in the non-responder population
time frame: 12 months
Efficacy of treatment strategies used to treat non-responders as determined by the rate of response in non-responders to CRT
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.