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

Primary Purpose

Hypertension,Essential

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Catheter-Based Carotid Body Ablation
Sponsored by
Cibiem, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension,Essential

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Adelaide Hospital
  • Fiona Stanley Hospital
  • Royal Perth Hospital
  • Na Homolce Hospital
  • Clinic Cardiology and Angiology II
  • Cardiovascular Center Frankfurt (CVC Frankfurt)
  • Klinik für Innere Medizin III

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Catheter-Based Carotid Body Ablation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Mean reduction in office systolic and diastolic blood pressure, and home systolic and diastolic blood pressure
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
Ventricular morphometric improvements from cardiac MRI measurements

Full Information

First Posted
October 15, 2017
Last Updated
April 6, 2018
Sponsor
Cibiem, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03314012
Brief Title
First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension
Official Title
First-In-Human Study for Ultrasound Based Endovascular Carotid Body Ablation in Subjects With Treatment-Resistant Hypertension: A Safety and Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2015 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cibiem, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catheter-Based Carotid Body Ablation
Arm Type
Experimental
Arm Description
All subjects undergo catheter-based ablation of the carotid body using the Cibiem Transvenous Ultrasound System (CTUS).
Intervention Type
Device
Intervention Name(s)
Catheter-Based Carotid Body Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety as assessed by incidence of major adverse events
Description
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.
Time Frame
From procedure to one month post-procedure
Title
Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure
Time Frame
Baseline versus six months post-procedure
Secondary Outcome Measure Information:
Title
Composite rate of major adverse events
Description
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
Time Frame
At 6, 12, 18, and 24 months post-procedure
Title
Mean reduction in office systolic and diastolic blood pressure, and home systolic and diastolic blood pressure
Time Frame
Baseline versus 3, 6, 12, 18, and 24 months
Title
Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure
Description
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
Time Frame
At 6, 12, 18, and 24 months
Title
Ventricular morphometric improvements from cardiac MRI measurements
Time Frame
Screening versus 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Schlaich, Professor
Organizational Affiliation
Royal Perth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Clinic Cardiology and Angiology II
City
Bad Krozingen
Country
Germany
Facility Name
Cardiovascular Center Frankfurt (CVC Frankfurt)
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Klinik für Innere Medizin III
City
Homburg
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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