Endovascular Carotid Body Ablation in Patients With Treatment- Resistant Hypertension: A Safety and Feasibility Study.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Noblewell
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Adverse events
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a prospective, observational, multicenter trial to evaluate the safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension. All patients will be followed for two (2) years following treatment.
Detailed Description
The investigators propose a new method of treatment, unilateral carotid body ablation, for treatment- resistant hypertensive patients to restore more normal blood pressure control, which will reduce cardiovascular morbidity and mortality in these patients. This strategy will increase the number of therapeutic options available to many patients and their physicians as well as offering the potential of normal blood pressure to those patients in whom blood pressure remains elevated despite vigorous, drug or device based therapies.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age of participants will be 18-75 years.
- •Treatment-resistant hypertensive subjects on medical management.
- •Office systolic blood pressure (oBP) ≥ 160mmHg.
- •Daytime mean ambulatory BP (ABPM) ≥ 140 mmHg.
- •Persistent hypertension on at least three anti-hypertensive medications, including a diuretic, at stable, maximum tolerated dose within the last 90 days.
- •No evidence for causes of secondary HTN (hypertension ) following thorough clinical assessment.
- •At least one carotid body detected in CT angiography of the neck, defined as an hyper-enhanced ovoid structure strongly located poster-medially from the area of carotid bifurcation.
- •Ability to give and giving informed consent to participate in the study.
- •Women of child-bearing potential have a negative pregnancy test.
Exclusion Criteria
- •Calculated GFR (glomerular filtration rate) \< 30ml/min/m2
- •Obstructive carotid atherosclerotic disease which precludes safe delivery of ablation catheter or performance of ablation
- •Must be at least 6 months post renal denervation therapy.
- •Oxygen saturation at rest below 92%.
- •Requirement for oxygen therapy to maintain oxygen saturation.
- •Severe untreated obstructive sleep apnea (defined as an apnea-hypopnea index (AHI) ≥ 30/hour during Polysomnography associated with an average minimum oxygen desaturation of \< 85%.
- •Patients wish to participate in mountain climbing, sky diving or free diving.
- •Pregnancy or anticipation of pregnancy.
- •Acute coronary syndrome or unstable angina \< 6 months before scheduled procedure.
- •History of repeated episodes of hypoglycemia with hypoglycemic unawareness.
Outcomes
Primary Outcomes
Adverse events
Time Frame: 3 months
Safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension employing a radiofrequency catheter designed specifically for this indication.
Secondary Outcomes
- Change of Blood Pressure(3 months)