NCT03314012

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

First-In-Human Study for Ultrasound Based Endovascular Carotid Body Ablation in Subjects With Treatment-Resistant Hypertension: A Safety and Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Cibiem, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypertension,Essential

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2015-12-11
• Primary completion: 2018-08-01
• Completion: 2020-01-01
• First posted: 2017-10-19
• Last updated: 2018-04-10

Locations

7 sites across 3 countries: Australia, Czechia, Germany

Regulatory

• FDA-regulated device study