Coverage with Evidence Development for Artificial Hearts
Guidance for NCD for Artificial Hearts concluded that additional clinical research would be appropriate under the Coverage with Evidence Development aspect of CMS’ coverage authority.
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: June 23, 2020
The NCD for Artificial Hearts, released by CMS in May 2008, concluded that additional clinical research would be appropriate under the Coverage with Evidence Development aspect of CMS’ coverage authority. The NCD specifies that artificial heart devices are covered only when provided to Medicare beneficiaries when the device is implanted as part of a CMS approved study. An artificial heart is an implanted prosthetic device that replaces the heart. As part of the artificial heart implantation, a substantial part of the biological heart is removed.
A clinical study must address one or more aspects of the following questions:
Were there unique circumstances such as expertise available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes?
What will be the average time to device failure when the device is made available to larger numbers of patients?
Do results adequately give a reasonable indication of the full range of outcomes (both positive and negative) that might be expected from more widespread use?
Approved Studies:
Study Title: SynCardia 50cc Temporary Artificial Heart (TAH-T) as a Bridge to Transplant (BTT) Study - Rev 005
Sponsor: SynCardia Systems, Inc.
ClinicalTrials.gov Number: NCT02459054
CMS Approval date: 10/6/2015
Study Title: SynCardia 70cc Temporary Artificial Heart (TAH-T) for Destination Therapy (DT) Study – Rev 003 (DT Study)
Sponsor: SynCardia Systems, Inc.
ClinicalTrials.gov Number: NCT02232659
CMS Approval date: 7/28/2015
Study Title SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection
Sponsor: SynCardia Systems, Inc
ClinicalTrials.gov Number: NCT01919320
CMS Approval date: 2/12/2014
Study Title: SynCardia Freedom Driver System Study
Sponsor: SynCardia Systems, Inc.
ClinicalTrials.gov Number: NCT00733447
CMS Approval Date: 4/20/2010
Study Title: A post-approval study to monitor the clinical performance of the AbioCor in severe end-stage heart disease
Sponsor: Abiomed, Inc.
ClinicalTrials.gov Number: NCT00669357
CMS Approval Date: 5/14/2008
Study Title: The SynCardia CardioWest TAH-t postmarket surveillance study
Sponsor: SynCardia Systems, Inc.
ClinicalTrials.gov Number: NCT00614510
CMS Approval Date: 5/14/2008
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