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Advance Cardiac Resynchronization Therapy (CRT) Registry

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Abbott

Status

Completed

Conditions

Heart Failure

Treatments

Device: CRT Patients

Study type

Observational

Funder types

Industry

Identifiers

NCT01805154
60046199

Details and patient eligibility

About

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.

Full 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 heart failure (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., atrioventricular and ventricle-to-ventricle interval optimization, left ventricular (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.

Enrollment

1,529 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,529 participants in 1 patient group

CRT patients
Description:
Patients who have received any market approved St Jude Medical CRT-D or CRT-P device
Treatment:
Device: CRT Patients

Trial documents
1

Trial contacts and locations

69

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Data sourced from clinicaltrials.gov

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