CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

Not Applicable

Active, not recruiting

• Conditions: Resistant Hypertension; Hypertension
• Interventions: Device: MobiusHD; Other: Sham Implantation

• Registration Number: NCT03179800
• Lead Sponsor: Vascular Dynamics, Inc.

Brief 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.

Detailed Description

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. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Study Start: 2017-10-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

• Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MobiusHD Implantation	MobiusHD	MobiusHD Implantation
Sham Implantation	Sham Implantation	Sham Implantation

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day	180-day	The primary effectiveness endpoint is change in mean 24-hr ambulatory systolic blood pressure (24hr sABP) from baseline to the 180-day visit.

Trial Locations

Locations (6)

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

St. Vincent Heart Center of Indiana; 🇺🇸 Indianapolis, Indiana, United States

The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Southern Illinois University; 🇺🇸 Springfield, Illinois, United States

CHU Nancy Centre Coeur et Vaisseaux; 🇫🇷 Nancy, France