Resistant Hypertension Drug resistant high blood pressure Refractory Hypertension
Conditions
Interventions
Light sedation and pain control is recommended to allow for clinical
neurological assessment as needed
Note: Diabetic subjects taking drugs containing metformin should be switched
to insulin managem
Sponsors
Vascular Dynamics, Inc. Clinical Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Baseline Screening Visit 1 - (Day 0 - 14) - Assessed on Day 14 1. Provided written informed consent; 2. >= 18 years of age and = 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 unless patient has history of intolerance, ineffectiveness or contraindications. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications); 4. Carotid duplex studies demonstrating no obstructive carotid disease or plaque 5. Renal artery imaging performed within the last 12 months showing no evidence of renal artery stenosis. Acceptable imaging modalities include renal duplex, magnetic resonance angiography, CT angiography, and selective or nonselective renal angiography depending on trial site diagnostic standards. In the absence of adequate imaging testing this inclusion criteria could also be met by obtaining a renal duplex prior to enrollment, or by performing nonselective renal angiography at the time of device implantation. 6. Compliant with medications (self-reported); and 7. For females (with child-bearing potential), a negative pregnancy test, and the use of a medically accepted method of birth control for the duration of the trial.;Baseline Screening Visit 2 - (Day 15 - 30) - Assessed on Day 30 1. No significant obstructive vascular disease or plaque on CTA or MRA of the aortic arch and great vessels; 2. Continued adherence to hypertension medications without anticipated changes; and 3. Continued office cuff SBP >= 160 mmHg despite 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. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril+HCTZ) equals two (2) anti-hypertensive medications).;Day of Procedure - 1. Continued adherence to hypertension medications without anticipated changes.
Exclusion criteria
Exclusion criteria: Baseline Screening Visit 1 - (Day 0 - 14) - Assessed on Day 14 1.Known or clinically suspected baroreflex failure or autonomic neuropathy; 2.Hypertension secondary to an identifiable and treatable cause other than sleep apnea; 3.Arm circumference greater than 46cm and/or BMI >= 40; 4.Chronic atrial fibrillation or recurrent atrial fibrillation with episode within the last 12 months; 5.Vulnerable plaque or ulceration of any size in the carotid artery or aortic arch; 6.History of bleeding complications with dual anti-platelet therapy in the past or has known uncorrectable bleeding diathesis; 7.Current use of additional anticoagulation therapy. (Examples include vitamin K antagonists like warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, thrombin IIa inhibitors like apixaban, rivaroxaban, dabigatran and etexilate; 8.Peptic ulcer disease with documented active ulcer or bleeding within the last year. 9.History of allergy to contrast dye that cannot be managed medically; 10.History of orthostatic hypotension; 11.History of syncope within the last six (6) months; 12.History of myocardial infarction or unstable angina within the past three (3) months; 13.History of cerebral vascular accident (stroke or TIA) within the past year; 14.Severe chronic kidney disease (calculated GFR 11.75 mm. 2.Carotid hypersensitivity detected by carotid massage or typical history, as described in the Protocol (Appendix V); or 3.Significant aortoiliac or common femoral artery disease that will prohibit safe femoral access 4. Mean 24-hour ambulatory blood pressure < 130/80 mmHg.;Day of Procedure - Angiographic 1. Evidence of plaque, ulceration or any stenosis by angiographic evaluation in orthogonal views of the carotid artery. Lumen diameters will be assessed to exclude subjects with ICA lumen diameters smaller than 5 mm or larger than 11.75 mm. 2. Any plaque or ulceration on the arch angiogram involving the aortic arch and/or the origin of the great vessels; 3. Inappropriate anatomy of the carotid bifurcation for deployment of the MobiusH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance: Decrease in office cuff blood pressure (BP) | — |
Countries
Netherlands
Outcome results
None listed