Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

ROX Medical

Status and phase: Completed; Phase 3

Conditions: Blood Pressure, High; Hypertension; Blood Pressure, Resistant; Blood Pressure, Uncontrolled

Treatments: Device: ROX COUPLER

Study type: Interventional

Funder types: Industry

Identifiers

NCT01885390

RH-03

Details and patient eligibility

About

The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.

Enrollment: 83 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.

Exclusion criteria

• Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

Experimental: Group A

Experimental group

Description:

ROX Coupler + continuing standard antihypertensive medications

Treatment:

Device: ROX COUPLER