- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01844037
OneShot Renal Denervation Registry
August 31, 2015 updated by: Medtronic Endovascular
Renal Denervation Using the OneShot Ablation System
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Milano, Italy
- Hospital San Raffaele
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Renal denervation
Patients will be treated with the OneShot ablation system
|
Renal denervation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in office systolic blood pressure (SBP) from baseline to 6 months
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.
Time Frame: One Week
|
One Week
|
Change in office diastolic blood pressure (DBP)
Time Frame: 6 and 12 months post procedure
|
6 and 12 months post procedure
|
Change in office SBP
Time Frame: 6 and 12 months post procedure
|
6 and 12 months post procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
April 29, 2013
First Submitted That Met QC Criteria
April 30, 2013
First Posted (Estimate)
May 1, 2013
Study Record Updates
Last Update Posted (Estimate)
September 2, 2015
Last Update Submitted That Met QC Criteria
August 31, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP1002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
US Department of Veterans AffairsCompleted
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
Clinical Trials on OneShot Ablation System
-
Medtronic EndovascularWithdrawnResistant Hypertension | Uncontrolled Hypertension | Renal Artery AblationItaly
-
Medtronic EndovascularMedtronic - MITG; Meditrial Europe Ltd.CompletedHypertension, Resistant to Conventional TherapyNetherlands, Germany, Belgium, Italy, Luxembourg, New Zealand
-
Covidien, GI SolutionsCompletedESOPHAGEAL SQUAMOUS CELL CARCINOMAChina
-
Pentax MedicalCompletedEsophageal CancerUnited States
-
Medtronic - MITGCompletedHIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial LesionsUnited States
-
Medtronic CardiovascularCompletedAtrial FibrillationUnited States
-
Medtronic Cardiac Rhythm and Heart FailureCompleted
-
Abbott Medical DevicesTerminated
-
Thermedical, Inc.CompletedTachycardia, VentricularCanada
-
Medtronic CardiovascularCompleted