Principal Investigator: Craig Selzman
Keywords: LVAD , Heart Failure , Cardiology , Cardiothoracic Surgery , Echocardiography Department: Cardiothoracic Division
IRB Number: 00118407
Specialty: Cardiology, Cardiology, Cardiothoracic Surgery, Cardiology, Cardiology
Sub Specialties: Heart Failure, Cardiac Mechanical Support, Echocardiography, Heart Transplant
Recruitment Status: Not yet recruiting

Contact Information

Scott Lawson
scott.lawson@hsc.utah.edu
801-581-5834

Brief Summary

This study is comprised of 2 amendments that fall under an umbrella Product Surveillance Registry that has been created by the sponsor Medtronic (the introduction/mentioning of the PSR is for contextual clarifications only) :

  1. Medtronic Product Surveillance Registry (PSR) - (Document: PSR_Base_CIP_MCS_Version2_12JAN2018) This is Medtronic's version of an Umbrella Protocol for all of their products. There are 2 Amendments (discussed below) to this PSR registry that correspond specifically to this IRB study:
    1. Destination Therapy Post Approval Study (DT PAS) Addendum - (Document: DT PAS PSR Addendum Version 2_23May2018) which is an Addendum to the PSR. This is a registry study specific to the Medtronic product HeartWare Ventricular Assist Device (HVAD). This is a Data Collection (umbrella) Protocol only. All procedures are Standard of Care for HVAD patients. This registry last 5 years.
    2. Apogee addendum to the DT PAS - (Document: Apogee Addendum Version 1_27JUL2018) This is an addendum to the DT PAS study and is designed as an optional sub-study/co-enrollment to the DT PAS. This sub-study/co-enrollment is OPTIONAL: Participants can choose to be a part of DT PAS and not take part in the sub-study Apogee, or they can be in both (participants must be enrolled in DT PAS to be in Apogee, see diagram below for visual representation). This is a Data Collection (umbrella) Protocol only. All procedures are Standard of Care for HVAD patients. Specifically to Apogee, there are patient entered Blood Pressure Diary entries and extra imaging views taken during SOC echocardiograms. The Apogee data is captured for 1 year (see option 2 diagram below).

Patients can choose to be a part of DT PAS registry alone (Option 1 below). Or they can choose to participate in the optional Apogee study in conjunction with DT PAS (Option 2 below).

From the Medtronic PSR and DT PAS:

  • Provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use.
  • To further confirm safety and effectiveness of the HVAD System when used as intended for DT, in “real-world” clinical practice a network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used
  • Leverage a common infrastructure and CIP framework to facilitate early post approval leading edge performance assessment via the least burdensome approach in large populations over time
  • Support post-market surveillance activities initiated by Medtronic and Post-Approval Studies conducted to fulfill government and/or regulatory authority requests

From the Apogee addendum to DT PAS:

The purpose of Apogee is to collect additional information to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation / antiplatelet therapies. The goals of Apogee are:

  • To evaluate collective impact of Apogee standardized guidelines and characterize impact on 12-month aggregate adverse event rate
  • To better understand the effects of implant technique and patient management on clinical outcomes

Apogee co-enrollment portion of this study will not be done at the VAMC:

Due to echo imaging requirements of the Apogee study (training of VAMC echo staff and uploading the echocardiograms to the Apogee echo core lab that would be required of the VAMC echo lab) Apogee co-enrollment portion will not be included at the VAMC. Since it’s a sub-study and participants are consenting to Apogee separately, VA subjects can still do the main registry DT PAS.

Inclusion Criteria

The target populations are the same at the VAMC as the University of Utah Hospital.

From the Medtronic Product Surveillance Registry:

7.3. Inclusion Criteria

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive or be treated with an eligible product (Medtronic HVAD)
  • Patient is consented within the enrollment window of the treatment/therapy received, refer to the applicable Condition/Therapy Appendix.

From the DT PAS PSR Addendum:

Patients intended to be implanted with a HVAD for use as a destination therapy are eligible for enrollment into the DT PAS and must be consented for the PAS prior to the HVAD implant.

From the Apogee Addendum:

Subjects consented to participate in the DT PAS are eligible for participation in Apogee.

 

Exclusion Criteria

The target populations are the same at the VAMC as the University of Utah Hospital.

From the Medtronic Product Surveillance Registry (same for DT PAS PSR Addendum):

7.4. Exclusion Criteria

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)

From the Apogee Addendum:

There are no exclusion criteria unique to Apogee.