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

Hypertension,Essential Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03314012
• Other study ID #: CL1008
• Status: Active, not recruiting
• Phase: N/A
• First received: October 15, 2017
• Last updated: April 6, 2018
• Start date: December 11, 2015
• Est. completion date: January 2020

Study information

• Verified date: April 2018
• Source: Cibiem, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: January 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension,Essential

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Czechia	Na Homolce Hospital	Prague
Germany	Clinic Cardiology and Angiology II	Bad Krozingen
Germany	Cardiovascular Center Frankfurt (CVC Frankfurt)	Frankfurt
Germany	Klinik für Innere Medizin III	Homburg

Sponsors (1)

Lead Sponsor	Collaborator
Cibiem, Inc.

Countries where clinical trial is conducted

Australia,  Czechia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by incidence of major adverse events	Safety assessed as the combined rate of major adverse events defined as all-causes of death, hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications, and any device or procedure-related serious adverse event.	From procedure to one month post-procedure
Primary	Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure		Baseline versus six months post-procedure
Secondary	Composite rate of major adverse events	Safety assessed as the combined rate of major adverse events defined as all-causes of death and hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications	At 6, 12, 18, and 24 months post-procedure
Secondary	Mean reduction in office systolic and diastolic blood pressure, and home systolic and diastolic blood pressure		Baseline versus 3, 6, 12, 18, and 24 months
Secondary	Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure	Controlled blood pressure is defined as office blood pressure <140/90 mmHg, mean 24-hr ABP <130/80 mmHg, daytime ABP <135/85 mmHg, and mean nighttime ABP <120/70 mmHg	At 6, 12, 18, and 24 months
Secondary	Ventricular morphometric improvements from cardiac MRI measurements		Screening versus 12 and 24 months