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

NCT03314012 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-04-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cibiem, Inc.

    lead INDUSTRY

Principal Investigators

  • Markus Schlaich, Professor · Royal Perth Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-11
Primary Completion
2018-08-31
Completion
2020-01-31
FDA Device
Yes

Countries

  • Australia
  • Czechia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03314012 on ClinicalTrials.gov