CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Mean 24 hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed, (JNC8) or their equivalent when those listed are not available dosing regimen consisting of up to 5 antihypertensive medications, with a minimum required dosing regimen of an A+C+D antihypertensive medication regimen, where A is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, C is a calcium channel blocker, and D is a diuretic.
Locations
United States
Georgia
Emory University Hospital Midtown
Atlanta
Illinois
Southern Illinois University
Springfield
Indiana
St. Vincent Heart Center of Indiana
Indianapolis
Louisiana
Ochsner Medical Center
New Orleans
Ohio
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati
Other Locations
France
CHU Nancy Centre Coeur et Vaisseaux
Nancy
Time Frame
Start Date: 2017-10-19
Completion Date: 2025-05
Participants
Target number of participants: 300
Treatments
Experimental: MobiusHD Implantation
MobiusHD Implantation
Sham_comparator: Sham Implantation
Sham Implantation
Authors
Chandan M Devireddy, Sandeep Nathan, Marc A Passman, Vincent M Figueredo, John J Szawaluk, Jesus O Navarro, Brian Bigelow, Mitra Nadim, Suzanne Oparil, Farrell Mendelsohn, Jon George, Paris P Bransford, Randolph R Rough, Atul Chugh, Michael J Bloch, Vivek Bhalla, Vijay Vidyasagar, Pankaj Gupta, Christopher R Provenzano, Aldo Peixoto, John M Flack, Rodolfo P Sotolongo, Michael E Cash, Michael S Levy, Saihari Sadanandan, John R Kotter, Sung Ham, Felix Mahfoud, Claire Mounier-Vehier, Munir Pirmohamed, Saleh Lamin, Michael Fischereder, Patrick Rossignol, Michael Okorie, Luke Laffin, Indranil Dasgupta, Jeffrey Turner, Janice Lea, Melvin Lobo, Philip J Chowienczyk, Wilko Spiering, Bryan Williams, Anthony Heagerty
Related Therapeutic Areas
Sponsors
Leads: Vascular Dynamics, Inc.