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Completed

NCT Number: NCT01805154

Advance Cardiac Resynchronization Therapy (CRT) Registry

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion Favaloro para la Docencia e Inv. med., Buenos Aires, Riodepl, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRT Patients

Device

This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.

Other names: St Jude Medical, Any approved CRT device

Primary outcomes

  1. Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response

    Time frame: 6 months

    • The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score.
    • Sites used their own clinical criteria (could include hospitalizations, functional assessments, etc.)

  2. Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT

    Time frame: 6 months

    Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status.

  3. Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months

    Time frame: Between 6 and 12 months

  4. Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months

    Time frame: Between 6 and 12 months

    Improvement in NYHA Class determined by improvement by at least 1 class.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Mar 6, 2013
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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