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Completed

NCT Number: NCT00442286

Rheos® Pivotal Trial

The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with hypertension that are resistant to treatment with at least three anti-hypertension agents, one of which is a diuretic.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Hochschule Hannover, Hanover, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be at least 21 years of age and no more than 80 years of age.
  • Have been assessed with bilateral carotid bifurcations that are easily interrogated by carotid duplex ultrasound and are below the level of the mandible.
  • Office cuff systolic blood pressure greater than or equal to 160 mmHg and have a diastolic blood pressure greater than or equal to 80 mmHg as well as a 24-hour ambulatory systolic blood pressure greater than or equal to 135 mmHg despite at lest one month of maximally tolerated therapy with at least three anti-hypertensive medications, of which at least one must be a diuretic.
  • Must have completed the drug compliance questionnaire and have been judged to be compliant with medications.
  • For subjects that have had prior bariatric surgery, they must be at least 1 year post-surgery and at a stable weight.
  • If female, the subject must be surgically sterile, or using a medically accepted method of birth control and agree to continue use of this method for the duration of the trial. Women of childbearing potential must have a negative serum pregnancy test in the pre-implant blood evaluation.
  • Must be an appropriate or reasonable surgical candidate.
  • Have signed a CVRx approved informed consent form for participation in this study

Exclusion criteria

  • Have known or suspected baroreflex failure or autonomic neuropathy.
  • Have an arm circumference greater than 46 cm and/or body mass index of greater than 45.
  • Have significant cardiac bradyarrhythmias.
  • Have chronic atrial fibrillation.
  • Have significant orthostatic hypotension
  • Had a solid organ or hematologic transplant.
  • Had a myocardial infarction, unstable angina, syncope, or cerebral vascular accident within the past 3 months.
  • Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within 6 months of enrollment in the trial.
  • Have ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
  • Have prior surgery, radiation, or endovascular stent placement in either carotid sinus region.
  • Have severe chronic kidney disease as defined by:
  • Currently undergoing dialysis or dialysis is planned within 3 months of the implant date
  • eGFR of ≤30 ml/min/1.73m²
  • Have hypertension secondary to an identifiable and treatable cause other than sleep apnea.
  • Have clinically significant cardiac structural valvular disease.
  • Have clinically significant reactive airway disease, chronic obstructive pulmonary disease, and/or primary pulmonary hypertension.
  • Have an uncontrolled comorbid medical condition that would adversely affect participation in the trial.
  • Have a clinically significant psychological illness that would prohibit the subject's ability to meet the protocol requirements
  • Are currently taking an imidazolone receptor agonist
  • Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
  • Have an active infection within the last month.
  • Have a co-morbid condition that reduces life expectancy to less than one year.
  • Are enrolled in another concurrent clinical trial, without prior approval of CVRx.

Treatment and study plan

Rheos® Baroreflex Hypertension System

Device

Electrical activation of the Carotid Baroreflex

Primary outcomes

  1. Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure

    Time frame: 6 months post-activation

    Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) via a double-blind, randomized, parallel group, super-superiority design for proportion of subjects that achieve at least a 10 mm Hg drop in systolic blood pressure at Month 6 compared to Month 0, with a superiority margin of 20%.

  2. Percent of Group A (Rheos® Device On) Patients Who Maintain a 10 mm Hg Drop in Systolic Blood Pressure at 12 Months Post-activation, and Whose Response at 12 Months is at Least 50% of the Response Observed at 6 Months Post-activation.

    Time frame: 12 months post-activation

    Compare the sustained response in SBP Month 12 in Group A ( Rheos® Device On ) responders at Month 6 to an objective performance criterion of 65%. A sustained response to therapy required the reduction from Month 0 to Month 12 to be at least 10 mmHg and to remain at least 50% of that seen at Month 6.

  3. Serious Procedure- or System-related Adverse Event-free Rate in Both Implanted and Attempted Patients

    Time frame: 30 days post implant

    Compare the serious procedure- or system-related adverse event-free rate for events occurring within 30 days of implant to a pre-specified objective performance criterion of 82% set based on historical literature on implantable cardioverter defibrillators (ICD) and pacemakers.

    Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort.

  4. Major Hypertension-related and Serious Device-related Adverse Event-Free Rate in Both Implanted and Attempted Patients.

    Time frame: 12 months-post activation

    Compare the event-free rate for all major hypertension-related and serious device-related adverse events occurring between 30 days post-implant and the Month 12 visit, to a pre-specified objective performance criterion of 72% based on similar implantable devices such as defibrillators and resynchronization devices.

    Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort.

  5. Therapy-related Adverse Event-free Rate.

    Time frame: 6 months post-activation

    Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) therapy-related adverse event-free rates via a double-blind, randomized, parallel group, non-inferiority design for therapy-related serious adverse events occurring between 30 days post-implant and the Month 6 visit. The non-inferiority margin was 15%.

Sponsors and collaborators

Lead sponsor

CVRx, Inc.

Industry

Registry information

Official study title

Rheos® Pivotal Trial: Rheos™ Baroreflex Hypertension Therapy System

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2007
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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