The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

  • STATUS
    Recruiting
Updated on 30 March 2021
Investigator
Alexander Smith
Primary Contact
The Brigham and Women's Hospital (4.5 mi away) Contact
+20 other location

Summary

RADIANCE-II is a pivotal trial, currently enrolling patients, to study the safety and effectiveness of the Paradise System to reduce blood pressure in patients with hypertension, in the absence of antihypertensive medications. RADIANCE-II is currently enrolling patients with uncontrolled blood pressure on 0-2 medications.

 

Details
Condition High Blood Pressure (Hypertension)
Clinical Study IdentifierTX228474
Last Modified on30 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\- Previously or currently prescribed antihypertensive therapy
\- Average office BP ≥ 140/90 mmHg <180/120 mmHg while stable for at least 4
weeks on 0-2 classes of antihypertensive medication
\- Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week
washout/run-in period

Exclusion Criteria

\- Known, uncorrected causes of secondary hypertension other than sleep apnea
\- Type I diabetes mellitus or uncontrolled Type II diabetes
\- eGFR of <40
\- Brachial circumference ≥ 42 cm
\- Any history of cerebrovascular event or severe cardiovascular event, or
history of stable or unstable angina within 12 months prior to consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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