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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vascular Dynamics, Inc.
Sponsor:
Information provided by (Responsible Party):
Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01831895
First received: April 9, 2013
Last updated: June 26, 2014
Last verified: June 2014
History of Changes

April 9, 2013
June 26, 2014
May 2013
June 2014   (final data collection date for primary outcome measure)
Safety [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01831895 on ClinicalTrials.gov Archive Site
PERFORMANCE [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Decrease in office cuff blood pressure (BP).
PERFORMANCE [ Time Frame: 6 Months ]
Decrease in office cuff blood pressure (BP).
Not Provided
Not Provided
 
Controlling and Lowering Blood Pressure With The MOBIUSHD™
CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study

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

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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Device: MobiusHD™
Implant that is placed in the carotid sinus to control hypertension.
Experimental: MobiusHD™
MobiusHD™
Intervention: Device: MobiusHD™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2016
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Sujith J Shetty, MBBS 650-963-9370 sshetty@vasculardynamics.com
United States
 
NCT01831895
CALM-FIM_US, CRD0152, G130013
Yes
Vascular Dynamics, Inc.
Vascular Dynamics, Inc.
Not Provided
Principal Investigator: Mark C Bates, MD West Virginia University
Vascular Dynamics, Inc.
June 2014

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