First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-11

Study Completion Date

2020-01-31

Brief Summary

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The carotid body is located at the bifurcation of the internal and external carotid arteries. It is a chemoreceptor that plays a role in the sympathetic nervous system and in the development and maintenance of hypertension. Hypertension is a major cardiovascular risk factor and is associated with coronary artery disease, stroke, chronic kidney disease, and heart failure.

The objective of this study is to assess the effectiveness and safety of a catheter-based system to ablate the carotid body and reduce blood pressure (BP) in patients with resistant hypertension and to confirm sustainability of the treatment benefits long-term as seen following surgical CB removal.

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Detailed Description

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Conditions

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Hypertension,Essential

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Catheter-Based Carotid Body Ablation

All subjects undergo catheter-based ablation of the carotid body using the Cibiem Transvenous Ultrasound System (CTUS).

Group Type EXPERIMENTAL

Catheter-Based Carotid Body Ablation

Intervention Type DEVICE

The Cibiem Transvenous Ultrasound System (CTUS) is a catheter based device delivering ultrasound energy to ablate the carotid body. The procedure is done via a percutaneous insertion of the CTUS and advancement through the femoral vein to the jugular vein in subjects with difficult to control hypertension. The procedure duration is expected to range between 60 to 90 minutes and is performed under fluoroscopic and ultrasound image guidance.

Interventions

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Catheter-Based Carotid Body Ablation

The Cibiem Transvenous Ultrasound System (CTUS) is a catheter based device delivering ultrasound energy to ablate the carotid body. The procedure is done via a percutaneous insertion of the CTUS and advancement through the femoral vein to the jugular vein in subjects with difficult to control hypertension. The procedure duration is expected to range between 60 to 90 minutes and is performed under fluoroscopic and ultrasound image guidance.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mean office SBP ≥160 mmHg and DBP ≥90 mmHg during screen-in period
* Mean daytime systolic ABPM ≥135 mmHg during screen-in period
* Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic), with no medication changes expected for at least six (6) months post-procedure
* No change in anti-hypertensive drug prescription (dose, number of medications, or class of medication) for at least six (6) weeks prior to enrollment
* Negative pregnancy test for women of child-bearing age
* Willingness and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria

* Secondary causes of hypertension
* Calculated eGFR \<30mL/min/1.73m2
* History of repeated episodes of hypoglycemic unawareness
* Morbid obesity, defined as Body Mass Index \>40 kg/m2
* Severe obstructive sleep apnea (AHI \> 35/hr.)
* Pacemaker and/or implantable defibrillators
* History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening
* History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening
* History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No