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

• Sponsor: Cibiem, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03314012
• Collaborator: (none)
• Enrollment: 39
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 48.7
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential	Device: Catheter-Based Carotid Body Ablation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: First-In-Human Study for Ultrasound Based Endovascular Carotid Body Ablation in Subjects With Treatment-Resistant Hypertension: A Safety and Feasibility Study
• Actual Study Start Date: Dec 11, 2015
• Anticipated Primary Completion Date: Aug 1, 2018
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Catheter-Based Carotid Body Ablation All subjects undergo catheter-based ablation of the carotid body using the Cibiem Transvenous Ultrasound System (CTUS).

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.

Outcome Measures

Primary Outcome Measures

1. Safety as assessed by incidence of major adverse events [From procedure to one month post-procedure]

   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.

2. Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure [Baseline versus six months post-procedure]

Secondary Outcome Measures

1. Composite rate of major adverse events [At 6, 12, 18, and 24 months post-procedure]

   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

2. 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]

3. Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure [At 6, 12, 18, and 24 months]

   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

4. Ventricular morphometric improvements from cardiac MRI measurements [Screening versus 12 and 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
2	Fiona Stanley Hospital	Murdoch	Western Australia	Australia	6150
3	Royal Perth Hospital	Perth	Western Australia	Australia	6000
4	Na Homolce Hospital	Prague		Czechia	15030
5	Clinic Cardiology and Angiology II	Bad Krozingen		Germany
6	Cardiovascular Center Frankfurt (CVC Frankfurt)	Frankfurt		Germany	60389
7	Klinik für Innere Medizin III	Homburg		Germany	66421

Sponsors and Collaborators

• Cibiem, Inc.

Investigators

• Principal Investigator: Markus Schlaich, Professor, Royal Perth Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cibiem, Inc.
• ClinicalTrials.gov Identifier: NCT03314012
• Other Study ID Numbers: CL1008
• First Posted: Oct 19, 2017
• Last Update Posted: Apr 10, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Apr 10, 2018