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CALM-FIM (Controlling and Lowering Blood Pressure with the MobiusHD™)

Last Updated 7/2/2014 1:42:45 PM


Summary:

The worldwide prevalence of hypertension (HTN) continues to rise.1 Of those diagnosed with HTN, an estimated 12-15% suffer a condition referred to as resistant HTN2, defined by the American Heart Association (AHA) as blood pressure that remains above goal in spite of concurrent use of three (3) antihypertensive medications3. Left uncontrolled, patients with elevated systolic blood pressure > 160 mmHg face a 4x increased risk of suffering a heart attack, stroke, or end stage kidney failure.4

Recently, device-based approaches have emerged as alternatives to controlling drug-resistant hypertension. One such alternative under evaluation at El Camino Hospital is the MobiusHD, a percutaneously placed nitinol implant intended for the treatment of resistant HTN.

Delivered using a .014” guide-wire compatible rapid exchange catheter, the MobiusHD nitinol implant is placed at the carotid sinus under the guidance of routine fluoroscopy. Placement of the MobiusHD is similar to procedures already being performed at El Camino, such as carotid stenting and cardiac stenting. Once placed, the device is intended to trigger a response in the carotid sinus that may lead to a sustainable decrease in blood pressure. The procedure is performed in a standard cardiology cath lab and patients are typically discharged within 24 hours.

El Camino Hospital's Dr. James Joye is one of the Principle Investigators in the CALM-FIM study, a controlled, open-label, multicenter trial evaluating the MobiusHD system in patients with stage II resistant hypertension. Dr. Ajanta De recently joined the study as Co-Investigator.

Eligibility:

  • Between the ages of 18-80 years
  • At least one (1) month of maximally tolerated therapy with three (3) anti-hypertensive drugs, at least one (1) of which must be a diuretic (water pill)
  • Office cuff SBP > 160 mmHg
  • No evidence of renal artery stenosis
  • Compliant with medications and 80% compliant with patient diary BP measurements

Enrollment and more information:

For more information about the study and/or to refer a patient, please contact the study Clinical Research Coordinator, Betty deBettencourt, at 650-962-4566 or via e-mail at Betty_deBettencourt@fogartyinstitute.org

For more general information please visit www.clinicaltrials.gov/show/NCT01831895

Reference Sources:
1. Nature Reviews Nephrology 2013;9:51-8.
2. Circulation. 2012 April 3; 125(13); 1594-1596
3. Hypertension. 2008;51:1403-1419
4. Heart Disease and Stroke Statistics, AHA 2012 Update

Contact Information

Principal Investigator
James Joye, DO
Interventional Cardiologist
Advanced Cardiovascular Specialists
2490 Hospital Drive, Suite 311
Mountain View, CA 94040
650-962-4690

Co-Investigator
Ajanta De, MD
Ajanta_De@fogartyinstitute.org

Study Coordinator
Betty deBettencourt, RN, MS, CCRC
650-962-4566
Betty_deBettencourt@fogartyinstitute.org