The Sympara VIBE Study for Hypertension | NCT02250495

Studies
The Sympara VIBE Study for Hypertension

NCT02250495

Sponsor

Sympara Medical, Inc.

Status

Terminated

Last Update Posted

Sep 14, 2015Estimated

Enrollment

8Actual

Phase

Phase 1Phase 2

Conditions

Hypertension

Interventions

Sympara Therapeutic System

Countries

Australia

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company closed

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Sep 20, 2014

First Submission Date that Met QC Criteria

Sep 23, 2014

First Posted Date

Sep 26, 2014Estimated

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

Sep 11, 2015

Last Update Posted Date

Sep 14, 2015Estimated

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

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sympara Therapeutic System	Experimental	All subjects will wear for the Sympara device for 30 days	Device: Sympara Therapeutic System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sympara Therapeutic System	Device	Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension	Sympara Therapeutic System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with serious, device-related adverse events as a measure of safety and tolerability		30 days

Secondary Outcomes

Measure	Description	Time Frame
Number of subjects with a reduction in baseline blood pressure following 30 days of Sympara device use as a measure of efficacy	Evaluating change in office, home and ambulatory blood pressure measurements at 30 days compared to baseline	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour Ambulatory Blood Pressure Measurement
Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician
Minimum six- (6) month history of diagnosis and treatment of hypertension

Exclusion Criteria:

Previous renal denervation or carotid barostimulation implant
Secondary causes of hypertension or primary pulmonary hypertension
Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
Known or suspected baroreflex failure or significant orthostatic hypotension
One or more hospital admissions for a hypertensive crisis within the past year
History of myocardial infarction, fibrillation event, unstable angina pectoris, syncope, transient ischemic attach (TIA) or a cerebrovascular accident within six (6) months of the screening period, or has widespread atherosclerosis with documented intrasvascular thrombosis or unstable plaques
Diabetes mellitus (Type 1)
Chronic renal disease requiring dialysis
Kidney or liver transplant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Princess Alexandra Hospital		Woolloongabba	Queensland	4102	Australia
Monash Health

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases