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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheos ON | Other | Study participants in this arm will have the device turn on for six months and remains on. |
|
| Rheos OFF | Other | Study participants in this arm will have the device turned off for 6 months and then turned on. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess left ventricular mass index (LVMI). | at six months post- randomization. | |
| Assess safety by evaluating all adverse events. | through six months post -implant |
| Measure | Description | Time Frame |
|---|---|---|
| To assess difference between randomization groups in blood pressure changes, blood levels and quality of life. | six months post-implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerckhoff-Klinik Forschungsgesellschaft mbH | Bad Nauheim | 61231 | Germany | |||
| University of Cologne |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Cologne |
| 50924 |
| Germany |
| Krankenhaus Reinbek St.Adolfsstif | Hamburg-Reinbek | 21465 | Germany |
| Medizinische Hoschschule Hannover | Hanover | Germany |