Rheos® Diastolic Heart Failure Trial

NCT00718939 | Completed

• 1 other identifier: 360014
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

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.

Conditions

Diastolic Heart Failure

Keywords

Diastolic Heart Failure; Cardiac dysfunction; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Assess left ventricular mass index (LVMI).

  at six months post- randomization.

• Assess safety by evaluating all adverse events.

  through six months post -implant

Secondary Outcomes (1)

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

  six months post-implant

Study Arms (2)

Rheos ON

OTHER

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

Device: Rheos Baroreflex Activation Therapy System

Rheos OFF

OTHER

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

Device: Rheos Baroreflex Activation Therapy System

Interventions

Rheos Baroreflex Activation Therapy System DEVICE

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.

Rheos OFF; Rheos ON

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CVRx, Inc.: lead

Study Sites (4)

Kerckhoff-Klinik Forschungsgesellschaft mbH

Bad Nauheim, 61231, Germany

Location

University of Cologne

Cologne, 50924, Germany

Location

Krankenhaus Reinbek St.Adolfsstif

Hamburg-Reinbek, 21465, Germany

Location

Medizinische Hoschschule Hannover

Hanover, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Heart Failure, Diastolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Maximilian A Pichlmaier, MD

  Medizinische Hoschschule Hannover

  PRINCIPAL INVESTIGATOR

• Johannes Sperzel, MD

  Kerckhoff-Klinik Forschungsgesellschaft mbH

  PRINCIPAL INVESTIGATOR

• Prof. Uta Hoppe, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

• Herbert Naegele, MD

  Krankenhaus Reinbek St.Adolfsstif

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

DE (4)