Rapid Renal Sympathetic Denervation for Resistant Hypertension II

Resistant Hypertension Clinical Trial

— RAPID II  

Official title:

Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01939392
• Other study ID #: CP-1003
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: September 6, 2013
• Last updated: August 14, 2015
• Start date: September 2013
• Est. completion date: September 2018

Study information

• Verified date: August 2015
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Renal Artery Ablation
• Resistant Hypertension
• Uncontrolled Hypertension

Intervention

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

Locations

Country	Name	City	State
Italy	Hospital San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse event (MAE) rate through 30 days post randomization		30 days	Yes
Primary	Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization		6 months	No
Secondary	Acute Procedural Safety		30 days	Yes
Secondary	Chronic procedural safety		6 months	Yes
Secondary	Reduction in SBP by >10 mmHg at 6 months		6 months	No
Secondary	Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits		6, 12, 24, and 36 months	No