N/A
Completed N=1,529
Advance Cardiac Resynchronization Therapy (CRT) Registry
Source: ClinicalTrials.gov NCT01805154 ↗Enrolled (actual)
1,529
Serious AEs
14.8%
Results posted
Aug 2019
Primary outcomePrimary: Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response — 1061; 900 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response |
1061; 900 | — |
| PRIMARY Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT |
431; 847; 858 | — |
| PRIMARY Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months |
63; 197; 88; 319; 79; 53 | — |
| PRIMARY Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months |
93; 34 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01805154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.