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The *RADIANCE-HTN* Study A study of the ReCor Medical Paradise System in Clinical Hypertension

The *RADIANCE-HTN* Study A study of the ReCor Medical Paradise System in Clinical Hypertension - RADIANCE-HTN Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50414
Enrollment
35
Registered
2016-02-17
Start date
2016-03-11
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension

Interventions

RADIANCE Solo Cohort After providing informed consent, subjects with uncontrolled (average seated office BP >= 140/90 mmHg and = 140/90 mmHg and = 135/85 mmHg and =140/90 mmHg despite at least three

Sponsors

ReCor Medical BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Documented history of essential hypertension

Exclusion criteria

Exclusion criteria: Main renal artery diameter 8 mm,TRIO cohort only (enrolment SOLO cohort completed) Main renal artery length

Design outcomes

Primary

MeasureTime frame
The Primary Efficacy endpoint will be the same in the two cohorts but analyzed separately; reduction in average daytime ambulatory systolic BP from baseline to 2 months post procedure.—

Secondary

MeasureTime frame
Reduction in average 24-hr/night-time ambulatory systolic BP at 2 months post procedure Reduction in average daytime/24-hr/night-time diastolic BP at 2 months post procedure—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)