Cardiac Output Autonomic Stimulation Therapy for Heart Fa... | NCT02880683

Studies
Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study

NCT02880683

Sponsor

NeuroTronik Inc.

Status

Completed

Last Update Posted

Oct 13, 2016Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Cardiac Output, Low

Interventions

NeuroTronik CANS Therapy System

Countries

Paraguay

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Aug 10, 2016

First Submission Date that Met QC Criteria

Aug 22, 2016

First Posted Date

Aug 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

A single-center feasibility study performed in patients undergoing a planned cardiac catheterization. This study investigated the feasibility of the NeuroTronik CANS Therapy™ System to improve acute hemodynamics. Purpose-built stimulation catheters were percutaneously inserted into an upper venous structure near the heart via right femoral vein and or left subclavian vein access using standard introducers and techniques. Subjects were instrumented with left ventricular and femoral artery catheters for pressure measurement and stimulated for approximately 60 minutes. Baseline hemodynamic measures were collected before stimulation and compared to measured values during stimulation. Following completion of the protocol, all in-dwelling equipment and catheters were removed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm, transvenous cardiac autonomic nerve stimulation	Experimental		Device: NeuroTronik CANS Therapy System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeuroTronik CANS Therapy System	Device		Single arm, transvenous cardiac autonomic nerve stimulation

Measure	Description	Time Frame
Cardiac output		One hour

Measure	Description	Time Frame
Arterial blood pressure		One hour
Left ventricular pressure		One hour
Heart rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adrian Ebner, Medical Doctor	Facultad de Ciencias Medicas UNA Paraguay, Asuncion, Paraguay	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanatorio Italiano		Asunción			Paraguay

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002303	Cardiac Output, Low
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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