Rapid Renal Sympathetic Denervation for Resistant Hypertension II

NCT ID: NCT01939392

Last Updated: 2015-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-09-30

Brief Summary

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This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.

Detailed Description

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Conditions

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Resistant Hypertension Uncontrolled Hypertension Renal Artery Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Denervation

Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication.

Group Type EXPERIMENTAL

Renal Denervation (OneShot™ Renal Denervation System)

Intervention Type DEVICE

Optimal Medical Therapy

Subjects randomized to the control arm will be maintained on antihypertensive medications.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Renal Denervation (OneShot™ Renal Denervation System)

Intervention Type DEVICE

Other Intervention Names

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OneShot Ablation system Catheter-based renal denervation

Eligibility Criteria

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Inclusion Criteria

* Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
* Stable drug regimen including three or more anti-hypertensive medications including a diuretic

Exclusion Criteria

* Renal anatomy unsuitable for treatment
* Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
* Patient has Type I diabetes
* Has scheduled or planned surgery within the next 6 months
* Individual is pregnant nursing or plans to be pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Endovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dierk Scheinert, MD

Role: PRINCIPAL_INVESTIGATOR

Park-Krankenhaus Liepzig

Guiseppe Mancia, MD

Role: PRINCIPAL_INVESTIGATOR

Universita Minano-Bicocca, Ospedale San Gerardo di Monza

Locations

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Hospital San Raffaele

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CP-1003

Identifier Type: -

Identifier Source: org_study_id

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