Rheos® Diastolic Heart Failure Trial

Diastolic Heart Failure Clinical Trial

Official title:

Rheos® Diastolic Heart Failure Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718939
• Other study ID #: 360014
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: October 19, 2016
• Start date: July 2008
• Est. completion date: July 2012

Study information

• Verified date: October 2016
• Source: CVRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic

Intervention

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.

Locations

Country	Name	City	State
Germany	Kerckhoff-Klinik Forschungsgesellschaft mbH	Bad Nauheim
Germany	Krankenhaus Reinbek St.Adolfsstif	Hamburg-Reinbek
Germany	Medizinische Hoschschule Hannover	Hannover
Germany	University of Cologne	Koeln

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess left ventricular mass index (LVMI).		at six months post- randomization.	No
Primary	Assess safety by evaluating all adverse events.		through six months post -implant	Yes
Secondary	To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.		six months post-implant	No

External Links

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