Renal Denervation for High Blood Pressure
(RADIANCE-II Trial)

Recruiting in Palo Alto (17 mi)

+57 other locations

Overseen byAjay Kirtane, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: ReCor Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

Research Team

Ajay Kirtane, MD

Principal Investigator

Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation

Prof. Michel Azizi, MD, PhD

Principal Investigator

Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou

Eligibility Criteria

This trial is for adults with Stage II hypertension, who have been on 0-2 blood pressure medications. They should have a documented high blood pressure range and can't be on chronic oxygen support or have severe cardiovascular issues. Pregnant individuals or those with uncontrolled diabetes are excluded.

Inclusion Criteria

My blood pressure is between 135/85 and 170/105 mmHg after a 4-week period without medication.

My blood pressure is between 140/90 and 179/119 mmHg, and I've been stable on up to 2 blood pressure medications for at least 4 weeks.

I have been prescribed medication for high blood pressure.

Exclusion Criteria

I have high blood pressure in the lungs.

Night shift workers

Pregnant, nursing or planning to become pregnant

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Treatment Details

Interventions

Paradise Renal Denervation System (Renal Denervation System)
Renal Angiogram (Procedure)

Trial OverviewThe study tests the Paradise System's safety and effectiveness in lowering blood pressure compared to a renal angiogram procedure. Participants will either receive the Paradise treatment or undergo an angiogram without denervation.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Renal DenervationExperimental Treatment1 Intervention

Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)

Group II: Sham ControlPlacebo Group1 Intervention

Renal Angiogram