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

NCT03314012 | Unknown FDA Device

• 1 other identifier: CL1008
• Study Type: interventional
• Target: 39
• Locations: 3 countries
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

• Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure

  Baseline versus six months post-procedure

Secondary Outcomes (4)

• Composite rate of major adverse events

  At 6, 12, 18, and 24 months post-procedure

• 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

• Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure

  At 6, 12, 18, and 24 months

• Ventricular morphometric improvements from cardiac MRI measurements

  Screening versus 12 and 24 months

Study Arms (1)

Catheter-Based Carotid Body Ablation

EXPERIMENTAL

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

Device: Catheter-Based Carotid Body Ablation

Interventions

Catheter-Based Carotid Body Ablation 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.

Catheter-Based Carotid Body Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cibiem, Inc.: lead

Study Sites (7)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Clinic Cardiology and Angiology II

Bad Krozingen, Germany

Location

Cardiovascular Center Frankfurt (CVC Frankfurt)

Frankfurt, 60389, Germany

Location

Klinik für Innere Medizin III

Homburg, 66421, Germany

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Markus Schlaich, Professor

  Royal Perth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 19, 2017
• Study Start: December 11, 2015
• Primary Completion: August 1, 2018
• Study Completion: January 1, 2020
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); CZ (1); AU (3)