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Rheos® Diastolic Heart Failure Trial

NCT00718939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-10-21

No results posted yet for this study

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.

Conditions

  • Diastolic Heart Failure

Interventions

DEVICE

Rheos Baroreflex Activation Therapy System

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.

Sponsors & Collaborators

  • CVRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Maximilian A Pichlmaier, MD · Medizinische Hoschschule Hannover

  • Johannes Sperzel, MD · Kerckhoff-Klinik Forschungsgesellschaft mbH

  • Prof. Uta Hoppe, MD · University of Cologne

  • Herbert Naegele, MD · Krankenhaus Reinbek St.Adolfsstif

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00718939 on ClinicalTrials.gov