Rapid Renal Sympathetic Denervation for Resistant Hypertension II (RAPID II)

Medtronic

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Resistant Hypertension; Renal Artery Ablation; Uncontrolled Hypertension

Treatments: Device: Renal Denervation (OneShot™ Renal Denervation System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01939392

CP-1003

Details and patient eligibility

About

This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
• Stable drug regimen including three or more anti-hypertensive medications including a diuretic

Exclusion criteria

• Renal anatomy unsuitable for treatment
• Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
• Patient has Type I diabetes
• Has scheduled or planned surgery within the next 6 months
• Individual is pregnant nursing or plans to be pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Renal Denervation

Experimental group

Description:

Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication.

Treatment:

Device: Renal Denervation (OneShot™ Renal Denervation System)

Optimal Medical Therapy

No Intervention group

Description:

Subjects randomized to the control arm will be maintained on antihypertensive medications.