Baroreflex Activation Therapy in Heart Failure

This study is currently recruiting participants.

Verified May 2013 by CVRx, Inc.

Sponsor:

Information provided by (Responsible Party):

CVRx, Inc.

ClinicalTrials.gov Identifier:

NCT01484288

First received: November 29, 2011

Last updated: May 1, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 29, 2011

Last Updated Date

May 1, 2013

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in sympathetic nervous system activity at 6 months from baseline [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01484288 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Baroreflex Activation Therapy in Heart Failure

Official Title ^ICMJE

Baroreflex Activation Therapy in Heart Failure

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Device: Barostim Neo System

Baroreflex Activation Therapy using the Barostim Neo System

Other Names:

XR-1 System
Neo system

Study Arm (s)

Experimental: Device group

Barostim Neo system

Intervention: Device: Barostim Neo System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2014

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Cristiano Ferrari

cferrari@cvrx.com

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01484288

Other Study ID Numbers ^ICMJE

360025

Has Data Monitoring Committee

Yes

Responsible Party

CVRx, Inc.

Study Sponsor ^ICMJE

CVRx, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Edoardo G Gronda, MD, FESC

MultiMedica

Information Provided By

CVRx, Inc.

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top