Multi-electrode Radiofrequency Renal Denervation System F... | NCT01699529

Studies
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

NCT01699529

Sponsor

Medtronic Vascular

Status

Completed

Last Update Posted

Oct 26, 2016Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Uncontrolled Hypertension

Interventions

Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system

Countries

Australia
New Zealand

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

Sep 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Oct 2016Actual

First Submitted Date

Sep 21, 2012

First Submission Date that Met QC Criteria

Oct 1, 2012

First Posted Date

Oct 3, 2012Estimated

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 24, 2016

Last Update Posted Date

Oct 26, 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

This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renal Denervation	Experimental		Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system	Device	The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute safety as measured by procedural complications		1 month

Secondary Outcomes

Measure	Description	Time Frame
Change in Office Systolic Blood Pressure		Baseline to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individual is ≥ 18 and ≤ 80 years old.
Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.

Exclusion Criteria:

Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
Individual has type 1 diabetes mellitus
Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
Individual has primary pulmonary hypertension.
Individual is pregnant, nursing or planning to be pregnant.

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Whitbourn, MD	St Vincent's Hospital Melbourne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alfred Hospital		Melbourne	Victoria	3004	Australia
St. Vincent's Hospital Melbourne

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25982652	Derived	Whitbourn R, Harding SA, Walton A. Symplicity multi-electrode radiofrequency renal denervation system feasibility study. EuroIntervention. 2015 May;11(1):104-9. doi: 10.4244/EIJV11I1A18.