NCT02099851

Brief Summary

This is a prospective, observational, multicenter trial to evaluate the safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension. All patients will be followed for two (2) years following treatment.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable hypertension

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

March 26, 2014

Last Update Submit

October 14, 2016

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension employing a radiofrequency catheter designed specifically for this indication.

    3 months

Secondary Outcomes (1)

  • Change of Blood Pressure

    3 months

Study Arms (1)

Carotid body ablation

EXPERIMENTAL

Patients undergoing the unilateral endovascular ablation of the right or left carotid body.

Device: Carotid body ablation (Cibiem)

Interventions

Carotid body ablation (Cibiem)DEVICE
Also known as: Cibiem Carotid Body Modulation System
Carotid body ablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of participants will be 18-75 years.
  • Treatment-resistant hypertensive subjects on medical management.
  • Office systolic blood pressure (oBP) ≥ 160mmHg.
  • Daytime mean ambulatory BP (ABPM) ≥ 140 mmHg.
  • Persistent hypertension on at least three anti-hypertensive medications, including a diuretic, at stable, maximum tolerated dose within the last 90 days.
  • No evidence for causes of secondary HTN (hypertension ) following thorough clinical assessment.
  • At least one carotid body detected in CT angiography of the neck, defined as an hyper-enhanced ovoid structure strongly located poster-medially from the area of carotid bifurcation.
  • Ability to give and giving informed consent to participate in the study.
  • Women of child-bearing potential have a negative pregnancy test.

You may not qualify if:

  • Calculated GFR (glomerular filtration rate) \< 30ml/min/m2
  • Obstructive carotid atherosclerotic disease which precludes safe delivery of ablation catheter or performance of ablation
  • Must be at least 6 months post renal denervation therapy.
  • Oxygen saturation at rest below 92%.
  • Requirement for oxygen therapy to maintain oxygen saturation.
  • Severe untreated obstructive sleep apnea (defined as an apnea-hypopnea index (AHI) ≥ 30/hour during Polysomnography associated with an average minimum oxygen desaturation of \< 85%.
  • Patients wish to participate in mountain climbing, sky diving or free diving.
  • Pregnancy or anticipation of pregnancy.
  • Acute coronary syndrome or unstable angina \< 6 months before scheduled procedure.
  • History of repeated episodes of hypoglycemia with hypoglycemic unawareness.
  • Known diabetic autonomic neuropathy.
  • History of, or current atrial fibrillation (AF).
  • Life expectancy of less than 24 months due to other disease.
  • Intravenous or inhaled recreational drug use.
  • Excessive use of alcohol or sedatives (alcohol intake \> 28 units/week).
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Na Homolce Hospital, Roentgenova 2

Prague, 150 30, Czechia

Location

Department of Hypertension and Diabetology, Medical University of Gdansk

Gdansk, 80-952, Poland

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

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

March 26, 2014

First Posted

March 31, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2016

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

CZ(1)PL(1)