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Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients (EnligHTN I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01438229
First received: September 19, 2011
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ablation-induced Renal Sympathetic Denervation Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • All adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Office Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: renal artery ablation
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)
Catheter-based RF ablation in renal artery

Detailed Description:

Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension.

Safety Marker

  • All adverse events

Efficacy Marker

  • Office blood pressure
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438229

Locations
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Greece
Hippokration Hospital
Athens, Greece
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01438229     History of Changes
Other Study ID Numbers: CI-10-045-ID-HT, Arsenal
Study First Received: September 19, 2011
Last Updated: October 10, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Greece: National Organization of Medicines

Keywords provided by St. Jude Medical:
Catheter-based renal artery ablation
Hypertension
Resistant to Conventional Therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013