Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

• Sponsor: Medtronic Vascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01699529
• Collaborator: (none)
• Enrollment: 50
• Locations: 4
• Arm: 1
• Duration (Months): 49
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension	Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Renal Denervation	Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system; The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.

Outcome Measures

Primary Outcome Measures

1. Acute safety as measured by procedural complications [1 month]

Secondary Outcome Measures

1. Change in Office Systolic Blood Pressure [Baseline to 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Individual is ≥ 18 and ≤ 80 years old.

• Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings

• Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.

Exclusion Criteria:

• Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2

• Individual has type 1 diabetes mellitus

• Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.

• Individual has primary pulmonary hypertension.

• Individual is pregnant, nursing or planning to be pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alfred Hospital	Melbourne	Victoria	Australia	3004
2	St. Vincent's Hospital Melbourne	Melbourne	Victoria	Australia	3065
3	Epworth Hospital	Melbourne	Victoria	Australia	3069
4	Wellington Hospital	Wellington		New Zealand

Sponsors and Collaborators

• Medtronic Vascular

Investigators

• Principal Investigator: Robert Whitbourn, MD, St Vincent's Hospital Melbourne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Vascular
• ClinicalTrials.gov Identifier: NCT01699529
• Other Study ID Numbers: 10058715DOC
• First Posted: Oct 3, 2012
• Last Update Posted: Oct 26, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Oct 26, 2016