First-in-human study evaluating a novel catheter device in subjects with treatment-resistant hypertension: a safety and feasibility study.

First-in-human study for ultrasound based endovascular carotid body ablation in subjects with treatment-resistant hypertension: a safety and feasibility study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001280594

Enrollment

Registered

2015-11-24

Start date

2016-03-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective of this First-in-Human (FIH) evaluation is to assess the safety and effectiveness of the Cibiem Transvenous Ultrasound System (CTUS) for percutaneous unilateral carotid body ablation in subjects with difficult to control hypertension.

Interventions

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 though the femoral vein to the jugular vein in subjects with difficult to control hypertension. Duration of the procedure is expected to range between 60 to 90 minutes. Procedure performed under fluoroscopic and ultrasound imaging guidance.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Mean daytime systolic ABPM equal or greater than 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, unless diuretic intolerance is documented), with no medication changes expected for at least six (6) months post-procedure Willingness and able to comply with follow-up requirements Signed informed consent

Exclusion criteria

Secondary causes of hypertension Calculated eGFR smaller than 30mL/min/1.73m2 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 Life expectancy of less than 12 months due to other disease

Outcome results