Rheos® Diastolic Heart Failure Trial
This study has been completed.
Sponsor:
CVRx, Inc.
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT00718939
First received: July 17, 2008
Last updated: May 1, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diastolic Heart Failure |
Device: Rheos Baroreflex Activation Therapy System |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Rheos® Diastolic Heart Failure Trial |
Resource links provided by NLM:
Further study details as provided by CVRx, Inc.:
Primary Outcome Measures:
- Assess left ventricular mass index (LVMI). [ Time Frame: at six months post- randomizatiom. ] [ Designated as safety issue: No ]
- Assess safety by evaluating all adverse events. [ Time Frame: through six months post -implant ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess difference between randomization groups in blood pressure changes, blood levels and quality of life. [ Time Frame: six months post-implant ] [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Rheos ON
Study participants in this arm will have the device turn on for six months and remains on.
|
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.
|
|
Rheos OFF
Study participants in this arm will have the device turned off for 6 months and then turned on.
|
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.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718939
Locations
| Germany | |
| Kerckhoff-Klinik Forschungsgesellschaft mbH | |
| Bad Nauheim, Germany, 61231 | |
| Krankenhaus Reinbek St.Adolfsstif | |
| Hamburg-Reinbek, Germany, 21465 | |
| Medizinische Hoschschule Hannover | |
| Hannover, Germany | |
| University of Cologne | |
| Koeln, Germany, 50924 | |
Sponsors and Collaborators
CVRx, Inc.
Investigators
| Principal Investigator: | 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | CVRx, Inc. |
| ClinicalTrials.gov Identifier: | NCT00718939 History of Changes |
| Other Study ID Numbers: | 360014 |
| Study First Received: | July 17, 2008 |
| Last Updated: | May 1, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by CVRx, Inc.:
|
Diastolic Heart Failure Cardiac dysfunction Heart Failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Failure, Diastolic Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013