Expired Study
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Springfield, Illinois 62701


Purpose:

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.


Criteria:

Inclusion Criteria: - Systolic blood pressure of 160 mmHg or greater - On 3 or more antihypertensive medications - eGFR >= 45 mL/min Exclusion Criteria: - Renal artery abnormalities - Known secondary hypertension attributable to a cause other than sleep apnea - MI, angina, CVA within 6 months - Type 1 diabetes - Others


Study is Available At:


Original ID:

TP-040


NCT ID:

NCT00753285


Secondary ID:


Study Acronym:


Brief Title:

Renal Denervation in Patients With Refractory Hypertension


Official Title:

Renal Denervation in Patients With Refractory Hypertension


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medtronic Vascular


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

Official Name:Henry Krum, PhD
Principal Investigator
Monash University and the Alfred Hospital

Study Dates

Start Date:September 2008
Completion Date:May 2013
Completion Type:Actual
Primary Completion Date:May 2013
Primary Completion Type:Actual
Verification Date:May 2014
Last Changed Date:May 20, 2014
First Received Date:September 12, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Physiologic response to renal denervation (e.g., blood pressure reduction)
Time Frame:Through 3 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.
Time Frame:Through 3 years
Safety Issues:True

Study Interventions

Intervention Type:Device
Name:Renal Denervation with a catheter-based procedure
Description:Disruption of the renal nerves with a catheter-based procedure.
Arm Name:Denervation Group
Intervention Type:Procedure
Name:Denervation Group
Description:Single-arm denervation group
Arm Name:Denervation Group

Study Arms

Study Arm Type:Experimental
Arm Name:Denervation Group
Description:Denervation Group

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Medtronic Vascular

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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