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Rheos® Diastolic Heart Failure Trial

Primary Purpose

Diastolic Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Rheos Baroreflex Activation Therapy System

About this trial

This is an interventional treatment trial for Diastolic Heart Failure focused on measuring Diastolic Heart Failure, Cardiac dysfunction, Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be at least 21 years of age.
Have bilateral carotid bifurcations that are below the level of the mandible.
Have a left ventricular ejection fraction ≥ 45%.
Clinical Heart Failure with elevated BNP or NT-Pro-BNP.

Exclusion Criteria:

History of or suspected baroreflex failure or autonomic neuropathy.
History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease.
Organ or hematologic transplant.
History of prior surgery, radiation, or stent placement in carotid sinus region.
History of severe chronic kidney disease.
Life expectancy to less than one year.

Sites / Locations

Kerckhoff-Klinik Forschungsgesellschaft mbH
Krankenhaus Reinbek St.Adolfsstif
Medizinische Hoschschule Hannover
University of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Rheos ON

Rheos OFF

Arm Description

Study participants in this arm will have the device turn on for six months and remains on.

Study participants in this arm will have the device turned off for 6 months and then turned on.

Outcomes

Primary Outcome Measures

Assess left ventricular mass index (LVMI).

Assess safety by evaluating all adverse events.

Secondary Outcome Measures

To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.

Full Information

NCT ID

NCT00718939

First Posted

July 17, 2008

Last Updated

October 19, 2016

Sponsor

CVRx, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00718939

Brief Title

Rheos® Diastolic Heart Failure Trial

Official Title

Rheos® Diastolic Heart Failure Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CVRx, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diastolic Heart Failure

Keywords

Diastolic Heart Failure, Cardiac dysfunction, Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rheos ON

Arm Type

Other

Arm Description

Study participants in this arm will have the device turn on for six months and remains on.

Arm Title

Rheos OFF

Arm Type

Other

Arm Description

Study participants in this arm will have the device turned off for 6 months and then turned on.

Intervention Type

Device

Intervention Name(s)

Rheos Baroreflex Activation Therapy System

Intervention Description

The two (2) Rheos Carotid Sinus Leads conduct the activation energy from the Rheos Implantable Pulse Generator to the baroreceptors located on the left (Left Carotid Sinus Lead) and right (Right Carotid Sinus Lead) carotid sinus. This energy activates the baroreflex by inducing signals that the brain interprets as elevated blood pressure.

Primary Outcome Measure Information:

Title

Assess left ventricular mass index (LVMI).

Time Frame

at six months post- randomization.

Title

Assess safety by evaluating all adverse events.

Time Frame

through six months post -implant

Secondary Outcome Measure Information:

Title

To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.

Time Frame

six months post-implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be at least 21 years of age. Have bilateral carotid bifurcations that are below the level of the mandible. Have a left ventricular ejection fraction ≥ 45%. Clinical Heart Failure with elevated BNP or NT-Pro-BNP. Exclusion Criteria: History of or suspected baroreflex failure or autonomic neuropathy. History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease. Organ or hematologic transplant. History of prior surgery, radiation, or stent placement in carotid sinus region. History of severe chronic kidney disease. Life expectancy to less than one year.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maximilian A Pichlmaier, MD

Organizational Affiliation

Medizinische Hoschschule Hannover

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Johannes Sperzel, MD

Organizational Affiliation

Kerckhoff-Klinik Forschungsgesellschaft mbH

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Prof. Uta Hoppe, MD

Organizational Affiliation

University of Cologne

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Herbert Naegele, MD

Organizational Affiliation

Krankenhaus Reinbek St.Adolfsstif

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kerckhoff-Klinik Forschungsgesellschaft mbH

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Krankenhaus Reinbek St.Adolfsstif

City

Hamburg-Reinbek

ZIP/Postal Code

21465

Country

Germany

Facility Name

Medizinische Hoschschule Hannover

City

Hannover

Country

Germany

Facility Name

University of Cologne

City

Koeln

ZIP/Postal Code

50924

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.cvrx.com

Description

Related Info

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Rheos® Diastolic Heart Failure Trial

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