Artificial Heart Clinical Study Approvals
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.
Medicare provides coverage for artificial hearts under the Coverage with Evidence Development (CED) paradigm when the device is implanted as part of a CMS approved study. Detailed information regarding the CED criteria and CMS approval process are available in the National Coverage Determination.
CMS will maintain a list of all approved studies and post that list on this webpage.
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: 5/14/08
Sponsor: SynCardia Systems, Inc.
ClinicalTrials.gov Number: NCT00614510
CMS Approval Date: 5/14/08
Study Title: SynCardia Freedom Driver System Study
Sponsor: SynCardia Systems, Inc.
ClinicalTrials.gov Number: NCT00733447
CMS Approval Date: 4/20/10
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