Controlling and Lowering Blood Pressure With The MOBIUSHD™ (CALM-FIM_US)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Vascular Dynamics, Inc.

ClinicalTrials.gov Identifier:

NCT01831895

First received: April 9, 2013

Last updated: May 30, 2017

Last verified: May 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

April 9, 2013

Last Updated Date

May 30, 2017

Start Date ^ICMJE

May 2013

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: 6 month ]

Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADE) reported for the study population from implantation through six (6) months of follow-up.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01831895 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PERFORMANCE [ Time Frame: 6 Months ]

Decrease in office cuff blood pressure (BP).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Controlling and Lowering Blood Pressure With The MOBIUSHD™

Official Title ^ICMJE

CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Device: MobiusHD™

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

Study Arms

Experimental: MobiusHD™

MobiusHD™

Intervention: Device: MobiusHD™

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2020

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01831895

Other Study ID Numbers ^ICMJE

CALM-FIM_US, CRD0152, G130013

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Vascular Dynamics, Inc.

Study Sponsor ^ICMJE

Vascular Dynamics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mark C Bates, MD

West Virginia University

PRS Account

Vascular Dynamics, Inc.

Verification Date

May 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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