Renal Denervation in Patients With Chronic Heart Failure... | NCT01392196

Studies
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial

NCT01392196

Sponsor

Medtronic Vascular

Status

Terminated

Last Update Posted

Feb 1, 2017Estimated

Enrollment

39Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Renal Denervation

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No evidence of a physiological response; no significant safety concerns; post 24-month follow-up; Data Monitoring Committee agreed

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jul 7, 2011

First Submission Date that Met QC Criteria

Jul 11, 2011

First Posted Date

Jul 12, 2011Estimated

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

Jan 30, 2017

Last Update Posted Date

Feb 1, 2017Estimated

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

This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.

Detailed Description

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Other	Renal Denervation	Procedure: Renal Denervation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal Denervation	Procedure	Renal Denervation using the Symplicity Catheter in Heart Failure Population	Single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events		6 month

Secondary Outcomes

Measure	Description	Time Frame
Ventricular function as measured by Echocardiography		6 month
Renal function as measured by Glomerular Filtration Rate (GFR)		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart Failure patients NYHA Class II or III
Renal Impairment Left Ventricular Ejection Function <40%
GFR 30 to 75 mL/min/1.73m2
Optimal stable medical therapy

Exclusion Criteria:

Renal artery anatomy must be eligible for treatment as determined by Angiography, and
History of prior renal artery intervention
Single functioning kidney.
Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
Systolic BP < 90 mmHG

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry Krum, MD	The Alfred	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alfred Hospital		Melbourne	Victoria		Australia

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided