OneShot Renal Denervation Registry | NCT01844037

Studies
OneShot Renal Denervation Registry

NCT01844037

Sponsor

Medtronic Endovascular

Status

Terminated

Last Update Posted

Sep 2, 2015Estimated

Enrollment

51Actual

Phase

Phase 2Phase 3

Conditions

Hypertension
Heart Failure
Diabetes Mellitus
Sleep Apnea

Interventions

OneShot Ablation System

Countries

Italy

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

Aug 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Apr 29, 2013

First Submission Date that Met QC Criteria

Apr 30, 2013

First Posted Date

May 1, 2013Estimated

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

Aug 31, 2015

Last Update Posted Date

Sep 2, 2015Estimated

Description Module

Brief Summary

This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renal denervation	Other	Patients will be treated with the OneShot ablation system	Device: OneShot Ablation System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OneShot Ablation System	Device	Renal denervation	Renal denervation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in office systolic blood pressure (SBP) from baseline to 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.		One Week
Change in office diastolic blood pressure (DBP)		6 and 12 months post procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.
Patient is ≥ 18 years old.
Patient provided written informed consent.

Exclusion Criteria:

Patients who are pregnant, nursing, or planning to become pregnant.
Patients who have only one functioning kidney.
Allergy to contrast or known hypersensitivity to device materials
Patients with renal arteries < 4 mm in diameter.
Patients whose life expectancy is less than the planned period of study involvement.

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

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D006333	Heart Failure
D003920	Diabetes Mellitus
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided