NCT01438229

Brief Summary

This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable hypertension

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 21, 2015

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

September 19, 2011

Results QC Date

April 17, 2015

Last Update Submit

February 1, 2019

Conditions

Hypertension

Keywords

Catheter-based renal artery ablationHypertensionResistant to Conventional Therapy

Outcome Measures

Primary Outcomes (2)

  • Adverse Events

    All device or procedure related adverse events

    24 months

  • Office Systolic Blood Pressure Change

    Baseline to 6 months

Other Outcomes (28)

  • Office Diastolic BP Change

    Baseline to 6M

  • Office Systolic BP Change

    Baseline to 12M

  • Office Systolic BP Change

    Baseline to 18 months

  • +25 more other outcomes

Study Arms (1)

renal artery ablation

EXPERIMENTAL

Catheter-based RF ablation in renal artery

Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

Interventions

St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)DEVICE

Catheter-based RF ablation in renal artery

renal artery ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
  • Age ≥18 and ≤80 years old
  • Able and willing to provide written informed consent to participate in the study
  • Able and willing to comply with the required follow-up schedule

You may not qualify if:

  • Prior renal artery intervention (balloon angioplasty or stenting)
  • Evidence of renal artery atherosclerosis (defined as a stenotic severity of \>30%) in either renal artery
  • Multiple main renal arteries in either kidney
  • Main renal arteries \<4 mm in diameter or \<20 mm in length
  • eGFR of \<45 mL/min per 1.73 m2 using the MDRD formula
  • Type 1 diabetes
  • Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
  • Others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Hippokration Hospital

Athens, Greece

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Steven Madej
Organization
St. Jude Medical
smadej@sjm.com
651-756-2230

Study Officials

  • Vasilias Papademetriou, MD

    First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • Konstantinos Tsioufis, MD

    First Cardioligy Clinic, Hippokration Hospital, University of Athens, Greece

    PRINCIPAL INVESTIGATOR

  • Stephen Worthley, MD

    Cardiovascular Investigation Unit, Royal Adelaide Hospital, Adelaide, Australia

    PRINCIPAL INVESTIGATOR

  • Ian Meredith, MD

    Monash Medical Centre, Melbourne, Australia

    PRINCIPAL INVESTIGATOR

  • Derek Chew, MD

    Flinders Medical Centre, Adelaide, AUSTRALIA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 22, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2012

Study Completion

July 1, 2014

Last Updated

February 5, 2019

Results First Posted

May 21, 2015

Record last verified: 2019-02

Locations

AU(3)GR(1)