Co-Principal Investigators: Vivek Bhalla, MD, FASN, FAHA and Tara I. Chang, MD, MS, FASN
Co-Investigator: Jason Lee, MD Vascular surgery
Objectives: Trial to evaluate the safety and effectiveness of the MobiusHD System in patients with resistant hypertension (uncontrolled hypertension on 3-5 blood pressure medications, including a calcium channel blocker, diuretic and ACE-inhibitor or angiotensin receptor blocker). [t1]
Type of trial: double-blind, sham-controlled, multicenter clinical trial intended to support a premarket application for the MobiusHD System. The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Interventions: MobiusHD Implantation versus Sham Implantation
Follow-up: All randomized subjects followed for 5 years post-implantation.
Enrollment period: July 2019 – August 31, 2023 (Accepting patients)
Inclusion/Exclusion criteria: For more information, please visit the study website.
Contact person: Lani Lucente Demchak, MBA
Phone: Tel: (650) 725-4738
Fax : 650-721-1443