Cardiovascular Device Expertise
Aptiv Solutions has managed cardiovascular studies for a range of medical devices. The devices include ventricular assist devices, drug eluting stents, endovascular and carotid stents, and stem cell applications for treatment of AMI and CHF. The studies range from one site feasibility studies to 125 site pivotal trials, both in the US and in Europe. Our project managers and clinical research associates have extensive cardiovascular experience in both the clinical setting, as well as the clinical research area. We have experience with managing core labs, CECs and DSMBs, as well as providing the necessary clinical data for regulatory submissions. Listed below are summaries of recent cardiovascular projects:
- Ventricular Assist Devices (VADs) – Clinical services for three VAD studies. We provided clinical monitoring services for a post-approval study. For the second study, we are providing full service clinical support, including clinical monitoring, study management, data management, CEC and DSMB activities, and statistical reporting and consulting; the study is a 40 site, four-year study. The third study involves data management and statistical services.
- Drug Eluting Stent – Clinical monitoring and project management services for a 125-site study involving 1,400 subjects, with a study duration of seven years
- Stem Cell treatment for AMI and CHF – Clinical activities for three studies. We are providing full service activities on two studies and monitoring services only on a third.
- Endovascular Stents – Clinical monitoring, auditing, and project management services for two endovascular stent devices involving eleven separate study protocols. The eleven different studies included a range of 20 to 100 sites per study protocol, and a total of over 2,500 subjects. Study subjects were followed for a five-year period.
- CHF Device – Full service clinical activities for a study with a novel approach to treat the underlying mechanisms responsible for congestive heart failure. This study involved 40 sites and enrolled 200 subjects. Services included clinical monitoring, study management, data management, CEC and DSMB activities, and statistical reporting and consulting.
- Groin Access Closure Device – Clinical monitoring, data management, study management, management of CEC and DSMB activities, statistical reporting, clinical report writing and preparation of the clinical section of the PMA. The study was conducted at eight study sites with 450 patients enrolled.
