NCT03179800

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable hypertension

Geographic Reach
2 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

7.5 years

First QC Date

May 30, 2017

Last Update Submit

July 17, 2024

Conditions

HypertensionResistant Hypertension

Keywords

HypertensionResistant HypertensionBaroreceptorBAT

Outcome Measures

Primary Outcomes (1)

  • Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 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.

    180-day

Other Outcomes (1)

  • Safety Assessments - Composite measured at 90-day

    90-day

Study Arms (2)

MobiusHD Implantation

EXPERIMENTAL

MobiusHD Implantation

Device: MobiusHD

Sham Implantation

SHAM COMPARATOR

Sham Implantation

Other: Sham Implantation

Interventions

MobiusHDDEVICE

The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.

MobiusHD Implantation
Sham ImplantationOTHER

Sham Implantation

Sham Implantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Southern Illinois University

Springfield, Illinois, 62702, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

CHU Nancy Centre Coeur et Vaisseaux

Nancy, 54035, France

Location

Related Publications (1)

  • Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156. No abstract available.

    PMID: 30407514DERIVED

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Bryan Williams, MD

    University College, London

    STUDY CHAIR

  • Gregg Stone, MD

    Cardiovascular Research and Education Columbia University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 7, 2017

Study Start

October 19, 2017

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations

US(5)FR(1)