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The Global cVAD Registry Protocol


Title The Global cVAD Registry Protocol
Therapeutic Area Cardiac Failure, Heart Diseases, Congestive Heart Failure, Heart Failure
Principal Investigator Navin Kapur, MD
Min Age 18 Years
Gender All
Contact Corinne Pellows
617 636-4884

Overview

The global cVAD registry collects clinical and procedural data retrospectively from hospital medical records for patients who received one or multiple Impella devices during routine clinical care. Patients who qualify for this registry include patients who received the Impella 2.5, Impella CP, or Impella 5.0 for left ventricular support as well as the Impella RP for right ventricular support during their inpatient stay. The registry is an observational, multicenter, retrospective records review. In order to best represent real-world practice, patients receiving Impella devices will be included in the registry without pre-selection. The purpose of the registry is to capture data that reflects "real world"? use of the Implella devices in clinical practice and provide insight into patients characteristics, comorbid conditions, patterns of care, quality of care and performance measurements.

Study Details

Inclusion Criteria

  • Patients who received mechanical circulatory support with an Impella device
  • Patients in whom an attempt was made to implant an Impella device

Exclusion Criteria

Study Requirements

If patients consent to participate in the long-term follow-up portion of the Registry, data will be collected through three (3) subject telephone interviews at 0 days, 90 days, and 1-uear after receiving an Impella implant. There are no additional required examinations or procedures, outside of standard care, that subjects will have to participate in for this registry.