Baroreflex Activation Therapy in Heart Failure

NCT ID: NCT01484288

Last Updated: 2021-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device group

Barostim Neo system

Group Type EXPERIMENTAL

Barostim Neo System

Intervention Type DEVICE

Baroreflex Activation Therapy using the Barostim Neo System

Interventions

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Barostim Neo System

Baroreflex Activation Therapy using the Barostim Neo System

Intervention Type DEVICE

Other Intervention Names

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XR-1 System Neo system

Eligibility Criteria

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Inclusion Criteria

* Age at least 21 years
* Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks

Exclusion Criteria

* Significant carotid plaque or stenosis
* Known or suspected baroreflex failure or autonomic neuropathy
* Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
* Heart failure secondary to a reversible condition
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CVRx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edoardo G Gronda, MD, FESC

Role: PRINCIPAL_INVESTIGATOR

MultiMedica

Locations

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MultiMedica

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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360025

Identifier Type: -

Identifier Source: org_study_id

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