OneShot Renal Denervation Registry

Hypertension Clinical Trial

Official title:

Renal Denervation Using the OneShot Ablation System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01844037
• Other study ID #: CP1002
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 29, 2013
• Last updated: August 31, 2015
• Start date: July 2014
• Est. completion date: March 2015

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 multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.

• Patient is = 18 years old.

• Patient provided written informed consent.

Exclusion Criteria:

• Patients who are pregnant, nursing, or planning to become pregnant.

• Patients who have only one functioning kidney.

• Allergy to contrast or known hypersensitivity to device materials

• Patients with renal arteries < 4 mm in diameter.

• Patients whose life expectancy is less than the planned period of study involvement.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Heart Failure
• Hypertension
• Sleep Apnea

Intervention

Device:
• OneShot Ablation System
Renal denervation

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	Change in office systolic blood pressure (SBP) from baseline to 6 months		6 months	No
Secondary	Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.		One Week	Yes
Secondary	Change in office diastolic blood pressure (DBP)		6 and 12 months post procedure	No
Secondary	Change in office SBP		6 and 12 months post procedure	No