NCT02880683

Brief Summary

A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

August 10, 2016

Last Update Submit

October 12, 2016

Conditions

Cardiac Output, Low

Keywords

Electrical Stimulation TherapyParasympathetic Nervous SystemSympathetic FibersPost GanglionicCongestive Heart FailureHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    One hour

Secondary Outcomes (3)

  • Arterial blood pressure

    One hour

  • Left ventricular pressure

    One hour

  • Heart rate

    One hour

Study Arms (1)

Single arm, transvenous cardiac autonomic nerve stimulation

EXPERIMENTAL
Device: NeuroTronik CANS Therapy System

Interventions

NeuroTronik CANS Therapy SystemDEVICE
Single arm, transvenous cardiac autonomic nerve stimulation

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable symptomatic heart failure - New York Heart Association Class II or III
  • Normal Sinus Rhythm

You may not qualify if:

  • Unable to gain arterial or venous access using standard percutaneous techniques
  • New York Heart Association Class IV
  • Patient taking amiodarone or other anti-arrhythmic therapy
  • Patients with implanted pacemaker, ICD, or CRT device
  • Patients who had CABG, PCI or enzyme-positive MI within prior month
  • Patients with pre-existing carotid artery or cerebral disease
  • Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
  • Patients who have been hospitalized for heart failure and who required the use of heart failure IV therapy within 30 days before enrollment (measured from release)
  • Patients with current or prior vagal nerve simulator
  • Patients with renal failure
  • Patients with hepatic failure
  • Patients with narrow angle glaucoma
  • Patients who are pregnant
  • Patients with a life expectancy \< 12 months per physician judgment
  • Patients with allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Cardiac Output, LowHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adrian Ebner, Medical Doctor

    Facultad de Ciencias Medicas UNA Paraguay, Asuncion, Paraguay

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 26, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

PA(1)