Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
Recruiting
N/A
Interventional Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 15 (estimated)
- Sponsor
- Microtech Medical Technologies, Ltd · Industry
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About This Trial
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient is scheduled to undergo an elective LVAD implantation via midline sternotomy based on routine practice at the participating center.
* Patient is characterized as INTERMACS profile 2 or greater.
* Patient is able and willing to provide written informed consent.
* Patien…
Contacts