NCT01911897

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable hypertension

Geographic Reach
2 countries

6 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

November 22, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

3.2 years

First QC Date

July 25, 2013

Results QC Date

October 4, 2023

Last Update Submit

November 20, 2023

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Serious Adverse Events (SAEs)

    The number of participants with serious adverse events reported in the study will be tabulated.

    36 months

Secondary Outcomes (2)

  • Systolic Office Cuff Blood Pressure (BP)

    Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months

  • Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months

    Baseline, 3 months, 6 months

Study Arms (1)

MobiusHD

EXPERIMENTAL

MobiusHD

Device: MobiusHD

Interventions

MobiusHDDEVICE

Implant that is placed in the carotid sinus to control hypertension.

MobiusHD

Eligibility Criteria

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

You may qualify if:

  • Office cuff SBP ≥ 160 mmHg measured per protocol instructions 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 unless patient has history of intolerance, ineffectiveness or contraindications.

You may not qualify if:

  • Known or clinically suspected baroreflex failure or autonomic neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Cologne

Cologne, 50937, Germany

Location

Maastricht University Medical Center

Maastricht, AZ, 6202, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3430 EM, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015, Netherlands

Location

HagaZiekenhuis

The Hague, 2545 CH, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3508 GA, Netherlands

Location

Related Publications (3)

  • van Kleef MEAM, Devireddy CM, van der Heyden J, Bates MC, Bakris GL, Stone GW, Williams B, Spiering W; CALM-FIM Investigators. Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study. JACC Cardiovasc Interv. 2022 Feb 14;15(3):321-332. doi: 10.1016/j.jcin.2021.12.015.

    PMID: 35144789RESULT

  • Spiering W, Williams B, Van der Heyden J, van Kleef M, Lo R, Versmissen J, Moelker A, Kroon A, Reuter H, Ansel G, Stone GW, Bates M; CALM-FIM_EUR investigators. Endovascular baroreflex amplification for resistant hypertension: a safety and proof-of-principle clinical study. Lancet. 2017 Dec 16;390(10113):2655-2661. doi: 10.1016/S0140-6736(17)32337-1. Epub 2017 Sep 1.

    PMID: 28870716DERIVED

  • Habib N, Mahmoodi BK, Bos WJ, Tromp SC, Suttorp MJ, Bates MC, Van der Heyden J. Initial experience with therapeutic geometric modification of the carotid bulb for true resistant hypertension. EuroIntervention. 2015 May;11(1):117-20. doi: 10.4244/EIJV11I1A20.

    PMID: 25982654DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Director, Clinical Operations
Organization
Vascular Dynamics
lgreen@vasculardynamics.com
9492317602

Study Officials

  • Jan Van der Heyden, MD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 30, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2016

Study Completion

February 28, 2020

Last Updated

November 22, 2023

Results First Posted

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)NL(5)