Controlling and Lowering Blood Pressure With The MOBIUSHD™

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: MobiusHD™

• Registration Number: NCT01831895
• Lead Sponsor: Vascular Dynamics, Inc.

Brief Summary

To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Detailed Description

This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the United States. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system.

Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.

Study Timeline

• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-15
• Study Start: 2013-05
• Disposition First Submitted: 2018-02-20
• Disposition First Submitted QC: 2018-02-22
• Disposition First Posted: 2018-02-26
• Primary Completion: 2020-07-08
• Study Completion: 2021-04-13
• Results First Submitted: 2021-12-14
• Results First Submitted QC: 2022-02-28
• Results First Posted: 2022-03-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Office cuff SBP ≥ 160 mmHg measured per protocol instructions (Appendix IV) following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications)

Exclusion Criteria

• Known or clinically suspected baroreflex failure or autonomic neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MobiusHD™	MobiusHD™	MobiusHD™

Primary Outcome Measures

Name	Time	Method
Adverse Events	3 years	Number of Participants with Adverse Events

Secondary Outcome Measures

Name	Time	Method
Change in Systolic Office Blood Pressure (OBP)	3 years	Change in Systolic Office Blood Pressure (OBP) compared to baseline.
Change in Systolic Ambulatory Blood Pressure (ABPM)	6 months	Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values.

Trial Locations

Locations (7)

Cardiology, P.C.; 🇺🇸 Birmingham, Alabama, United States

Turkey Creek Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Iowa Heart Center; 🇺🇸 Des Moines, Iowa, United States

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

University of Rochester; 🇺🇸 Rochester, New York, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States