Native Kidney Denervation in Patients With End Stage Rena... | NCT00551304

Studies
Native Kidney Denervation in Patients With End Stage Renal Disease

NCT00551304

Sponsor

Medtronic Vascular

Status

Completed

Last Update Posted

Nov 6, 2012Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

End Stage Renal Disease

Interventions

Ardian Catheter

Countries

Australia
Poland

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

Nov 2012

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 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 26, 2007

First Submission Date that Met QC Criteria

Oct 26, 2007

First Posted Date

Oct 30, 2007Estimated

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

Nov 2, 2012

Last Update Posted Date

Nov 6, 2012Estimated

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Ardian Catheter	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To provide confirmation that renal denervation in ESRD patients is safe and feasible.

Secondary Outcomes

Measure	Description	Time Frame
To provide evidence of denervation, indication of physiologic response, and assess device performance.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult >= 18 years of age
end stage renal disease, undergoing concurrent dialysis treatment
poorly controlled blood pressure on at least 2 antihypertensive drugs
agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits
competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

renal arterial abnormalities
myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months
hemodynamically significant valvular heart disease
implantable cardioverter defibrillator (ICD) or pacemaker
respiratory support.
pregnant, nursing or planning to be pregnant
other

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
Markus Schlaich, MD	The Alfred	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Alfred Hospital		Melbourne	Victoria	3004	Australia
John Paull II Hosptial

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22457244	Derived	Schlaich MP, Hering D, Sobotka PA, Krum H, Esler MD. Renal denervation in human hypertension: mechanisms, current findings, and future prospects. Curr Hypertens Rep. 2012 Jun;14(3):247-53. doi: 10.1007/s11906-012-0264-9.
21714604	Derived	Hering D, Esler MD, Krum H, Mahfoud F, Bohm M, Sobotka PA, Schlaich MP. Recent advances in the treatment of hypertension. Expert Rev Cardiovasc Ther. 2011 Jun;9(6):729-44. doi: 10.1586/erc.11.71.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases